CompletedNCT00553150Updated Feb 13, 2020Results posted

Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

A Phase 1/2 interventional study of everolimus and temozolomide in Brain and Central Nervous System Tumors, sponsored by Alliance for Clinical Trials in Oncology. Completed at 178 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 122
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking some of the blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with temozolomide and radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma.

Read the detailed description

OBJECTIVES:

To determine the maximum tolerated dose (MTD) of everolimus in combination with temozolomide and 3D-conformal radiotherapy or intensity-modulated radiotherapy (IMRT) followed by adjuvant temozolomide with or without everolimus in patients with newly diagnosed glioblastoma. (Mayo Clinic Rochester [MCR] AND Mayo Clinic Jacksonville [MCJ] patients only) (Phase I)
To assess and describe the adverse events of everolimus in combination with temozolomide and 3D-conformal radiotherapy or IMRT followed by adjuvant temozolomide with or without everolimus in patients with newly diagnosed glioblastoma. (MCR and MCJ patients only) (Phase I)
To assess treatment effectiveness of everolimus in combination with temozolomide and 3D-conformal radiotherapy or IMRT followed by adjuvant temozolomide with or without everolimus, until progression, in patients with newly diagnosed glioblastoma. (all North Central Cancer Treatment Group [NCCTG] patients) (Phase II)
To characterize the toxicities of everolimus in combination with temozolomide and 3D-conformal radiotherapy or IMRT followed by adjuvant temozolomide with or without everolimus in patients with newly diagnosed glioblastoma. (all NCCTG patients) (Phase II)
Evaluate whether suppression of fludeoxyglucose F18 (18FDG) uptake in tumor and normal brain can be used to determine a biologically effective dose for efficient penetration of everolimus through the blood-brain barrier. (MCR and MCJ patients only) (Phase I)
Correlate everolimus levels with 18FDG uptake suppression in tumor and normal brain. (MCR and MCJ patients only) (Phase I)
Assess the relationship between efficacy endpoints (i.e., survival, progression-free survival, and response) and changes in 3'-deoxy-3'-[18F]fluorothymidine (18F-FLT) uptake for patients treated at MCR. (all NCCTG patients) (Phase II)
Assess the relationship between efficacy endpoints (i.e., survival, progression-free survival, and response), and phospho-Akt, PTEN status, and MGMT expression and promoter methylation status. (all NCCTG patients) (Phase II)
Assess the relationship between efficacy endpoints (i.e., survival, progression-free survival, and response) and baseline gene expression signatures from paraffin embedded pre-treatment tumor samples. (all NCCTG patients) (Phase II)
Correlate gene expression between paraffin and frozen samples. (all NCCTG patients) (Phase II)
Evaluate potential mechanisms of therapy resistance in recurrent tumor samples obtained at the time of surgery for recurrent disease. (Phase I and II)

OUTLINE: This is a multicenter, phase I dose-escalation study of everolimus followed by a phase II study.

Phase I (Mayo Clinic Rochester [MCR] AND Mayo Clinic Jacksonville [MCJ] ONLY):
- Concurrent therapy (courses 1 and 2): Patients receive oral everolimus once weekly in weeks 1-7 or 1-8 and oral temozolomide once daily in weeks 2-7 or 3-8. Patients also undergo radiotherapy 5 days a week in either weeks 2-7 or 3-8. Four to six weeks later, patients proceed to adjuvant therapy. This rest period is defined as course 2.
- Adjuvant therapy with everolimus and temozolomide (courses 3-8): Patients receive oral everolimus on days 1, 8, 15, and 22 and oral temozolomide on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Adjuvant therapy with everolimus alone (courses 9 and all subsequent courses): Patients receive oral everolimus on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression our unacceptable toxicity.
Phase II (Open to MCR center ONLY) (All North Central Cancer Treatment Group [NCCTG] centers closed to accrual as of 02/17/11):
- Concurrent therapy (courses 1 and 2): Patients receive oral everolimus and oral temozolomide and 3D-conformal radiotherapy or IMRT as in phase I. Patients will undergo a 4-6 week rest period in course 2 and then proceed to adjuvant therapy.
- Adjuvant therapy with everolimus and temozolomide (courses 3-8): Patients receive oral everolimus and oral temozolomide as in phase I.
- Adjuvant therapy with everolimus alone (courses 9 and all subsequent courses): Patients receive oral everolimus as in phase I.

All patients undergo fludeoxyglucose (FDG)- or fluorothymidine-labeled PET/CT scans at baseline and periodically during treatment.

Patients undergo blood sample collection periodically for pharmacological studies. Samples are analyzed for everolimus blood levels and correlated with 18FDG uptake suppression in tumor and normal brain via LC-MSMS. Previously collected tumor tissue are analyzed for protein biomarkers including PTEN gene expression levels via fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) and phosphorylation on Ser473 and Ser308 of Akt and MGMT expression and promoter methylation via IHC. Samples are also analyzed for DNA sequencing. Some samples are banked for future studies.

After completion of study treatment, patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 138 patients (24 patients in phase I and 114 patients in phase II) will be accrued for this study.

Conditions studied

Brain and Central Nervous System Tumors

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Keywords

adult gliosarcoma
adult giant cell glioblastoma
adult glioblastoma
adult anaplastic astrocytoma
adult diffuse astrocytoma
adult pilocytic astrocytoma
adult subependymal giant cell astrocytoma

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 122 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of 1 of the following:
- Glioblastoma multiforme (grade 4 astrocytoma)
- Other grade 4 astrocytoma variants (e.g., giant cell)
  - No grade 4 oligodendrogliomas or oligoastrocytomas
- Gliosarcoma
Newly diagnosed disease
Measurable disease ≥ 1 cm³ (phase I patients only)
Some patients may be registered on protocol NCCTG-947252
No oligodendrogliomas or oligoastrocytomas

PATIENT CHARACTERISTICS:

Inclusion criteria:

ECOG performance status 0-2
ANC ≥ 1,500/μL
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/μL
Total bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)
Serum total cholesterol \< 350 mg/dL
Serum total triglycerides \< 400 mg/dL
AST ≤ 2.5 x ULN
Creatinine ≤ 1.5 x ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 60 days after completion of study therapy
Must be willing to undergo 2 mandatory research PET or PET/CT scans (all MCR and MCJ patients in phase I and MCR only patients in phase II)
Must be willing to abstain from eating or drinking grapefruit or grapefruit juice during study treatment
Must be willing to follow a diet low in fat and cholesterol while taking everolimus
Must be willing to have imaging scans submitted for central review
Ability to understand and willingness to sign a written informed consent

Exclusion criteria:

Other active cancers requiring therapy to control disease or prior cancer diagnoses which pose a greater than 30% risk of death within the next 2 years
Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active uncontrolled peptic ulcer disease
Uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing, uncontrolled, or active (acute or chronic) infection or disorder
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- Severely impaired lung function
- Uncontrolled diabetes (fasting serum glucose > 2 x ULN) OR diabetes that would interfere with the performance of the FDG-PET/CT or FDG-PET scans
- Liver disease (e.g., cirrhosis, chronic active hepatitis, chronic persistent hepatitis, or history of hepatitis B)
Known HIV positivity
Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests
Any history of allergy or intolerance to dacarbazine (DTIC)
Significant traumatic injury within the past 21 days
Severe allergy to sulfa medications
Inability to tolerate levofloxacin with dapsone or pentamidine (inhaled or IV)

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

At least 1 week, but no more than 6 weeks since prior surgical resection or biopsy
Must comply with antibiotic prophylaxis with either trimethoprim/sulfamethoxazole (daily or 3 times per week), oral dapsone (daily) combined with daily levofloxacin, or monthly pentamidine (inhaled or IV) combined with daily levofloxacin

Exclusion criteria:

Prior chemotherapy for any brain tumor
Prior temozolomide or mTOR inhibitor therapies
Any prior cranial radiotherapy
Planned immunization with attenuated live vaccines ≤ 7 days prior to and during study period
At least 21 days since prior major surgery (excluding neurosurgical biopsy, resection of brain tumor, or treatment of immediate post-neurosurgical complication [e.g., intracranial hematoma])
Concurrent or prior treatment for this cancer with any other investigational agents
Concurrent enzyme-inducing anticonvulsants (EIACs) or other strong inducers of CYP3A4 (i.e., carbamazepine, phenytoin, phenobarbital/primidone, rifabutin, rifampin, or St. John's wort)
Concurrent therapeutic doses of warfarin
- Low molecular weight heparin is allowed
Concurrent systematic leukocyte growth factors (e.g., G-CSF or GM-CSF), except for the treatment of severe neutropenia
Concurrent drugs or substances known to inhibit or induce CYP3A
Other concurrent chronic treatment with immunosuppressive agents except dexamethasone
Other concurrent anticancer agents
Concurrent live vaccines

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 122 participants (actual)

Study arms

Experimental
Everolimus (RAD001), Radiation (RT), Temozolomide (TMZ)
Patients receive oral everolimus and oral temozolomide and 3D-conformal radiotherapy or IMRT as in phase I. Patients will undergo a 4-6 week rest period in course 2 and then proceed to adjuvant therapy. Adjuvant therapy with everolimus and temozolomide (courses 3-8): Patients receive oral everolimus and oral temozolomide as in phase I. Adjuvant therapy with everolimus alone (courses 9 and all subsequent courses): Patients receive oral everolimus as in phase I. All patients undergo fludeoxyglucose (FDG)- or fluorothymidine-labeled PET/CT scans at baseline and periodically during treatment.
Drug: everolimus · Drug: temozolomide · Radiation: radiation

Interventions

Drugeverolimus
Drugtemozolomide
Radiationradiation

What researchers measure

Primary outcomes

Maximum Tolerated Dose (MTD) of Everolimus (RAD001) in Combination With Temozolomide (TMZ) and 3D-conformal Radiotherapy (RT) or Intensity-modulated Radiotherapy (IMRT) Followed by Adjuvant TMZ With or Without RAD001 (Phase I)
Patients were assessed during RT for dose-limiting toxicities (DLT), which were defined as failure to deliver greater than 75% of the planned doses of TMZ or RAD001 during RT, interruption of RT for more than 5 days because of toxicity, or the following: \>= Grade 3 diarrhea or skin rash; \>= Grade 4 neutropenia, leukopenia, or thrombocytopenia; \>= Grade 4 hypertriglyceridemia, hypercholesterolemia, or hyperglycemia despite optimal medial management, other \>= 3 non-hematologic events; or \>= Grade 4 radiation dermatitis. Maximum tolerated dose (MTD) was defined a priori as the highest dose level at which 0 or 1 of 6 patients developed DLTs. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.
Time frame: Up to 49 days
Overall Survival at 12 Months (Phase II)
The primary endpoint is overall survival at 12 months (OS12) after entry into this study. The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. A patient who is evaluable and survive more than 12 months (i.e. 365 days or more) after start of therapy will be classified as a "success". Patients who die within 12 months after start of therapy will be considered to have "failed".
Time frame: at 12 months

Secondary outcomes

Response Rate, as Measured in Patients Receiving FLT-PET Imaging (Phase II)
The response rate is defined as the percentage of patients receiving F-fluorothymidine positron emission tomography (FLT-PET) imaging whose cancer shrinks or disappears after treatment. A reduction in standardized uptake value (SUV) of 30% or greater in the T1-post-gadolinium scan volume of interest (T1-gad VOI) or the total tumor VOI will be considered a responsive tumor.
Time frame: Up to 5 years
Time to Progression (Phase II)
Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy. Patients who experience major treatment violations will be censored for progression on the date of treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.
Time frame: Up to 5 years
Progression-free-survival at 6 Months (Phase II)
Progression-free-survival at 6 months: is the proportion of patients alive and progression-free at 6 months after start of regimen. This proportion will be estimated using the binomial point estimator and the binomial 95% confidence interval estimated. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.
Time frame: at 6 months
Overall Survival Time
Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.
Time frame: Up to 15 years

Results

Posted Jan 11, 2017

Participant flow

Participant flow — Overall Study
Milestone	Phase I: Cohort/Dose Level 1 (30 mg RAD001)	Phase I: Cohort/Dose Level 2 (50 mg RAD001)	Phase 1: Cohort/Dose Level 3 (70 mg RAD001)	Phase II
Started	6	6	6	104
Completed	6	6	6	100
Not completed	0	0	0	4
Withdrew: Withdrawal by subject	0	0	0	2
Withdrew: Protocol violation	0	0	0	1
Withdrew: Ineligible	0	0	0	1

Outcome measures

PrimaryMaximum Tolerated Dose (MTD) of Everolimus (RAD001) in Combination With Temozolomide (TMZ) and 3D-conformal Radiotherapy (RT) or Intensity-modulated Radiotherapy (IMRT) Followed by Adjuvant TMZ With or Without RAD001 (Phase I)

Patients were assessed during RT for dose-limiting toxicities (DLT), which were defined as failure to deliver greater than 75% of the planned doses of TMZ or RAD001 during RT, interruption of RT for more than 5 days because of toxicity, or the following: \>= Grade 3 diarrhea or skin rash; \>= Grade 4 neutropenia, leukopenia, or thrombocytopenia; \>= Grade 4 hypertriglyceridemia, hypercholesterolemia, or hyperglycemia despite optimal medial management, other \>= 3 non-hematologic events; or \>= Grade 4 radiation dermatitis. Maximum tolerated dose (MTD) was defined a priori as the highest dose level at which 0 or 1 of 6 patients developed DLTs. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.

Time frame:: Up to 49 days
Reported as:: Number · participants who developed DLTs

Maximum Tolerated Dose (MTD) of Everolimus (RAD001) in Combination With Temozolomide (TMZ) and 3D-conformal Radiotherapy (RT) or Intensity-modulated Radiotherapy (IMRT) Followed by Adjuvant TMZ With or Without RAD001 (Phase I)
participants who developed DLTs	Phase I: Dose Level 0	Phase I: Dose Level 1	Phase I: Dose Level 2
Maximum Tolerated Dose (MTD) of Everolimus (RAD001) in Combination With Temozolomide (TMZ) and 3D-conformal Radiotherapy (RT) or Intensity-modulated Radiotherapy (IMRT) Followed by Adjuvant TMZ With or Without RAD001 (Phase I)	1	1	1

Statistical analysis

Phase I: Dose Level 0 vs Phase I: Dose Level 1 vs Phase I: Dose Level 2 · Maximum tolerated dose (mg): 70

PrimaryOverall Survival at 12 Months (Phase II)

The primary endpoint is overall survival at 12 months (OS12) after entry into this study. The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. A patient who is evaluable and survive more than 12 months (i.e. 365 days or more) after start of therapy will be classified as a "success". Patients who die within 12 months after start of therapy will be considered to have "failed".

Time frame:: at 12 months
Reported as:: Number · proportion of participants

Overall Survival at 12 Months (Phase II)
proportion of participants	Phase II
Overall Survival at 12 Months (Phase II)	0.64 (0.553 to 0.741)

SecondaryResponse Rate, as Measured in Patients Receiving FLT-PET Imaging (Phase II)

The response rate is defined as the percentage of patients receiving F-fluorothymidine positron emission tomography (FLT-PET) imaging whose cancer shrinks or disappears after treatment. A reduction in standardized uptake value (SUV) of 30% or greater in the T1-post-gadolinium scan volume of interest (T1-gad VOI) or the total tumor VOI will be considered a responsive tumor.

Time frame:: Up to 5 years
Reported as:: Number · percentage of participants

Response Rate, as Measured in Patients Receiving FLT-PET Imaging (Phase II)
percentage of participants	Phase II
Response Rate, as Measured in Patients Receiving FLT-PET Imaging (Phase II)	44.4 (15.3 to 77.3)

SecondaryTime to Progression (Phase II)

Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy. Patients who experience major treatment violations will be censored for progression on the date of treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.

Time frame:: Up to 5 years
Reported as:: Median · months

Time to Progression (Phase II)
months	Phase II
Time to Progression (Phase II)	6.4 (5.4 to 9.0)

SecondaryProgression-free-survival at 6 Months (Phase II)

Progression-free-survival at 6 months: is the proportion of patients alive and progression-free at 6 months after start of regimen. This proportion will be estimated using the binomial point estimator and the binomial 95% confidence interval estimated. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.

Time frame:: at 6 months
Reported as:: Number · proportion of participants

Progression-free-survival at 6 Months (Phase II)
proportion of participants	Phase II
Progression-free-survival at 6 Months (Phase II)	0.52 (0.431 to 0.628)

SecondaryOverall Survival Time

Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.

Time frame:: Up to 15 years
Reported as:: Median · months

Overall Survival Time
months	Phase II
Overall Survival Time	15.8 (13.0 to 20.3)

Adverse events

Collected over Adverse events were assessed weekly during Cycle 1, at the end of RT, prior to cycles 3-8, and during treatment with everolimus only until progression (Cycles ≥9). Only patients who had completed one cycle of treatment and completed an adverse event form were included in this adverse event table; Up to 5 years.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase I	—	5/18 (27.8%)	18/18 (100%)
Phase II	—	32/101 (31.7%)	99/101 (98%)

Most frequent serious events

Showing 10 of 56

Most frequent serious events
Event	Phase I	Phase II
ThrombosisVascular disorders	2/18	4/101
Neutrophil count decreasedInvestigations	1/18	10/101
Platelet count decreasedInvestigations	1/18	9/101
Hemoglobin decreasedBlood and lymphatic system disorders	1/18	3/101
Disease progressionGeneral disorders	1/18	1/101
FatigueGeneral disorders	1/18	3/101
Alanine aminotransferase increasedInvestigations	1/18	0/101
Aspartate aminotransferase increasedInvestigations	1/18	0/101
Bilirubin increasedInvestigations	1/18	0/101
Leukocyte count decreasedInvestigations	1/18	3/101

Most frequent other events

Showing 10 of 105

Most frequent other events
Event	Phase I	Phase II
Serum cholesterol increasedInvestigations	16/18	80/101
Platelet count decreasedInvestigations	15/18	64/101
Serum triglycerides increasedMetabolism and nutrition disorders	13/18	70/101
NauseaGastrointestinal disorders	8/18	68/101
Rash desquamatingSkin and subcutaneous tissue disorders	6/18	48/101
FatigueGeneral disorders	6/18	45/101
Neutrophil count decreasedInvestigations	7/18	42/101
DiarrheaGastrointestinal disorders	7/18	35/101
CoughRespiratory, thoracic and mediastinal disorders	6/18	38/101
DyspneaRespiratory, thoracic and mediastinal disorders	2/18	29/101

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Phase I	Phase II	Total
Median	57.5 (23 to 74)	61 (23 to 81)	60.5 (23 to 81)

Sex: Female, Male
Sex: Female, Male(Participants)	Phase I	Phase II	Total
Female	9	50	59
Male	9	54	63

Region of Enrollment
Region of Enrollment(participants)	Phase I	Phase II	Total
United States	18	104	122

Study locations

178 sites

Mayo Clinic Scottsdale
Scottsdale, Arizona 85259-5499, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut 06105, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho 83706, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois 61701, United States
St. Joseph Medical Center
Bloomington, Illinois 61701, United States
Graham Hospital
Canton, Illinois 61520, United States
Illinois CancerCare - Canton
Canton, Illinois 61520, United States
Illinois CancerCare - Carthage
Carthage, Illinois 62321, United States
Memorial Hospital
Carthage, Illinois 62321, United States
Eureka Community Hospital
Eureka, Illinois 61530, United States
Illinois CancerCare - Eureka
Eureka, Illinois 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois 61401, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois 61401, United States
Illinois CancerCare - Havana
Havana, Illinois 62644, United States
Mason District Hospital
Havana, Illinois 62644, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois 61443, United States
Illinois CancerCare - Macomb
Macomb, Illinois 61455, United States
McDonough District Hospital
Macomb, Illinois 61455, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois 61265, United States
Moline, Illinois 61265, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois 61462, United States
OSF Holy Family Medical Center
Monmouth, Illinois 61462, United States
BroMenn Regional Medical Center
Normal, Illinois 61761, United States
Community Cancer Center
Normal, Illinois 61761, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois 61554, United States
Illinois CancerCare - Pekin
Pekin, Illinois 61603, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois 61637, United States
Illinois CancerCare - Peru
Peru, Illinois 61354, United States
Illinois Valley Community Hospital
Peru, Illinois 61354, United States
Illinois CancerCare - Princeton
Princeton, Illinois 61356, United States
Perry Memorial Hospital
Princeton, Illinois 61356, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois 61362, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana 46107, United States
Reid Hospital & Health Care Services
Richmond, Indiana 47374, United States
McFarland Clinic, PC
Ames, Iowa 50010, United States
Bettendorf, Iowa 52722, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa 52403, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa 51102, United States
St. Luke's Regional Medical Center
Sioux City, Iowa 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas 67901, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas 67460, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas 67214, United States
CCOP - Wichita
Wichita, Kansas 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas 67214, United States
Wesley Medical Center
Wichita, Kansas 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas 67156, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan 48123-2500, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan 48503, United States
Hurley Medical Center
Flint, Michigan 48503, United States
Genesys Regional Medical Center
Grand Blanc, Michigan 48439, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan 48236, United States
Dickinson County Healthcare System
Iron Mountain, Michigan 49801, United States
Foote Memorial Hospital
Jackson, Michigan 49201, United States
Sparrow Regional Cancer Center
Lansing, Michigan 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan 48154, United States
St. Joseph Mercy Oakland
Pontiac, Michigan 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan 48601, United States
St. John Macomb Hospital
Warren, Michigan 48093, United States
MeritCare Bemidji
Bemidji, Minnesota 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota 55805, United States
Fairview Southdale Hospital
Edina, Minnesota 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota 55109, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota 55415, United States
New Ulm Medical Center
New Ulm, Minnesota 56073, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota 55905, United States

Showing the first 100 of 178 sites.

References and documents

Publications

Ma D, Galanis E, Schiff D, et al.: NCCTG N057K phase II trial of everolimus, temozolomide, and radiotherapy in patients with newly diagnosed glioblastoma: A North Central Cancer Treatment Group trial. [Abstract] J Clin Oncol 30 (Suppl 15): A-2031, 2012.
Sarkaria JN, Galanis E, Wu W, Peller PJ, Giannini C, Brown PD, Uhm JH, McGraw S, Jaeckle KA, Buckner JC. North Central Cancer Treatment Group Phase I trial N057K of everolimus (RAD001) and temozolomide in combination with radiation therapy in patients with newly diagnosed glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):468-75. doi: 10.1016/j.ijrobp.2010.05.064. Epub 2010 Sep 23. PubMed 20864273 ↗
Sarkaria JN, Peller PJ, Galanis E, et al.: FLT-PET analysis of early response to everolimus in newly diagnosed glioblastoma patients enrolled on NCCTG N057K. [Abstract] J Clin Oncol 29 (Suppl 15): A-e12501, 2011.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00553150
Lead sponsor: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Nov 4, 2007
Start date: Mar 2009
Primary completion: Jan 2012
Completion: Nov 15, 2019
Results posted: Jan 11, 2017
Last update: Feb 13, 2020

Study contacts

Jann N. Sarkaria, MD

study chair · Mayo Clinic

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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