A Phase 1/2 interventional study of radiation therapy and temozolomide in Adult Ependymoblastoma, Adult Giant Cell Glioblastoma and Adult Glioblastoma, sponsored by Lawrence Recht. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by Lawrence Recht · Phase 1/2, Interventional, and Treatment
This pilot phase I/II trial studies the side effects and best dose of plerixafor after radiation therapy and temozolomide and to see how well it works in treating patients with newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor after radiation therapy and temozolomide may be an effective treatment for high grade glioma.
PRIMARY OBJECTIVES:
I. To assess the safety of using continuous infusion Plerixafor subsequent to irradiation in patients with newly diagnosed glioblastoma multiforme (GBM).
II. To assess the efficacy of Plerixafor as measured by progression free survival at 6 months (PFS6) from the start of irradiation.
OUTLINE: This is a phase I, dose-escalation study of plerixafor followed by a phase II study.
Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide orally (PO) over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients receive plerixafor intravenously (IV) continuously for 2-4 weeks. Patients also receive temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.
After completion of study treatment, patients are followed up every 12 weeks for 5 years.
317 studies on the registry are indexed under Medulloblastoma; 51 are open to participants now.
This study's enrollment of 30 is close to the median of 31 across 255 interventional studies indexed under Medulloblastoma.
Browse Medulloblastoma studies →Lawrence Recht is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Medulloblastoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neuroectodermal Tumors, Primitive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate organ function is needed at time of screening visit including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide PO over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients receive plerixafor IV continuously for 2-4 weeks. Patients also receive temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.
Radiation: radiation therapy · Drug: temozolomide · Drug: plerixafor · Other: laboratory biomarker analysis · Other: pharmacological study
Undergo radiation therapy
Also known as: irradiation, radiotherapy, therapy, radiation
Given PO
Also known as: SCH 52365, Temodal, Temodar, TMZ
Given IV
Also known as: AMD 3100, Mozobil
Correlative studies
Correlative studies
Also known as: pharmacological studies
Dose-limiting Toxicity
Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)
Time frame: Up to 30 days post plerixafor
Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation
Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast summarized with Kaplan Meier estimates.
Time frame: 6 months from start of irradiation
A total of 30 patients were enrolled at one study center.
| Milestone | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day |
|---|---|---|---|
| Started | 3 | 6 | 21 |
| Completed | 3 | 6 | 20 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Unrelated adverse event | 0 | 0 | 1 |
Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)
| Participants | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day |
|---|---|---|---|
| Dose-limiting Toxicity | 0 | 0 | 0 |
Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast summarized with Kaplan Meier estimates.
| Participants | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day |
|---|---|---|---|
| Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation | 3 | 5 | 19 |
Collected over Up to 30 days after Plerixafor Infusion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Escalation: Plerixafor 200 mcg/kg/Day | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Escalation: Plerixafor 400 mcg/kg/Day | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Expansion: Plerixafor 400 mcg/kg/Day | 1/21 (4.8%) | 3/21 (14.3%) | 21/21 (100%) |
| Event | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day |
|---|---|---|---|
| PseudoprogressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3 | 0/6 | 0/21 |
| Abdominal PainGastrointestinal disorders | 0/3 | 0/6 | 1/21 |
| Disease ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 0/6 | 1/21 |
| EncephalopathyNervous system disorders | 0/3 | 0/6 | 1/21 |
| Hemorrhagic hepatic cystNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 0/6 | 1/21 |
| Event | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day |
|---|---|---|---|
| DiarrheaGastrointestinal disorders | 2/3 | 2/6 | 3/21 |
| InsomniaPsychiatric disorders | 1/3 | 4/6 | 7/21 |
| NauseaGastrointestinal disorders | 0/3 | 3/6 | 3/21 |
| ConjunctivitisEye disorders | 1/3 | 3/6 | 0/21 |
| DyspepsiaGastrointestinal disorders | 1/3 | 1/6 | 1/21 |
| HeadacheNervous system disorders | 1/3 | 2/6 | 4/21 |
| ParasthesiaNervous system disorders | 1/3 | 1/6 | 0/21 |
| FatigueGeneral disorders | 1/3 | 1/6 | 6/21 |
| Hot FlashesVascular disorders | 1/3 | 2/6 | 5/21 |
| HypertensionVascular disorders | 1/3 | 0/6 | 0/21 |
Only subjects who completed the 4 week infusion were included
| Age, Categorical(Participants) | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 15 | 20 |
| >=65 years | 1 | 3 | 5 | 9 |
| Age, Continuous(years) | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day | Total |
|---|---|---|---|---|
| Median | 64 (55 to 67) | 62 (40 to 74) | 60 (29 to 74) | 60 (29 to 74) |
| Sex: Female, Male(Participants) | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day | Total |
|---|---|---|---|---|
| Female | 2 | 2 | 5 | 9 |
| Male | 1 | 4 | 15 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 3 | 6 | 19 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 2 | 2 |
| White | 3 | 5 | 14 | 22 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Escalation: Plerixafor 200 mcg/kg/Day | Escalation: Plerixafor 400 mcg/kg/Day | Expansion: Plerixafor 400 mcg/kg/Day | Total |
|---|---|---|---|---|
| United States | 3 | 6 | 20 | 29 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Nov 2014, a primary completion of Nov 2017 and a completion of Sep 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2018, 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Temozolomide · Plerixafor
Lawrence Recht