A Phase 2 interventional study of Bevacizumab and Irinotecan Hydrochloride in Central Nervous System Neoplasm, Pineoblastoma and Recurrent Medulloblastoma, sponsored by National Cancer Institute (NCI). Completed at 158 sites in 5 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors.
PRIMARY OBJECTIVES:
l. To compare the overall survival (OS) of subjects receiving the combination of temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan (irinotecan hydrochloride), and bevacizumab for recurrent medulloblastoma (MB)/primitive neuroectodermal tumor (PNET) of childhood.
SECONDARY OBJECTIVES:
I. To assess the response rate for each treatment arm amongst patients who are enrolled with measurable disease.
II. To determine event-free survival (EFS) for each patient compared across regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive temozolomide orally (PO) and irinotecan hydrochloride IV over 90 minutes on days 1-5.
ARM II: Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
66 studies on the registry are indexed under Pinealoma; 11 are open to participants now.
This study's enrollment of 108 is above the median of 26 across 43 interventional studies indexed under Pinealoma.
Browse Pinealoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Compared within Pinealoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Central Nervous System Neoplasms. 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.
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Study specific limitations on prior therapy:
Patients must have recovered from any surgical procedure before enrolling on this study:
There should be no anticipation of need for major surgical procedures during the course of the study
Examples of major, intermediate, or minor surgical procedures:
Concomitant medications restrictions:
or radioisotope (GFR) >= 70 mL/min OR a serum creatinine based on age/gender as follows:
Central nervous system function defined as
Adequate coagulation defined as
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.
Drug: Irinotecan Hydrochloride · Drug: Temozolomide
Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
Biological: Bevacizumab · Drug: Irinotecan Hydrochloride · Drug: Temozolomide
Given IV
Also known as: ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev
Given IV
Also known as: Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, Irinomedac, Irinotecan Hydrochloride Trihydrate, Irinotecan Monohydrochloride Trihydrate, U-101440E
Given PO
Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
Overall Survival
Percentage Probability of remaining alive 5 years after enrollment estimated by the method of Kaplan and Meier
Time frame: Up to 5 years after enrollment
Response
Patient's best response during protocol therapy coded as complete response, partial response or no response.
Time frame: Up to 12 cycles of therapy (11 months)
Event-free Survival
Percentage Probability of remaining event-free 5 years after enrollment estimated by the method of Kaplan and Meier
Time frame: Up to 5 years after enrollment
| Milestone | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) |
|---|---|---|
| Started | 55 | 53 |
| Completed | 12 | 12 |
| Not completed | 43 | 41 |
| Withdrew: Adverse event | 0 | 8 |
| Withdrew: Death | 5 | 0 |
| Withdrew: Lack of efficacy | 29 | 25 |
| Withdrew: Physician decision | 8 | 5 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Ineligible | 1 | 1 |
Percentage Probability of remaining alive 5 years after enrollment estimated by the method of Kaplan and Meier
| percent probability | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) |
|---|---|---|
| Overall Survival | 2.43 (0.2 to 10.9) | 13.6 (4.7 to 27.1) |
Patient's best response during protocol therapy coded as complete response, partial response or no response.
| Participants | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) |
|---|---|---|
| Complete Response | 0 | 8 |
| Partial Response | 16 | 14 |
| No Response | 32 | 24 |
Percentage Probability of remaining event-free 5 years after enrollment estimated by the method of Kaplan and Meier
| percent probability | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) |
|---|---|---|
| Event-free Survival | 1.85 (0.15 to 8.62) | 15.4 (7.2 to 26.4) |
Collected over 12 cycles (planned 336 days of protocol therapy). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Temozolomide, Irinotecan Hydrochloride) | 48/54 (88.9%) | 9/54 (16.7%) | 31/54 (57.4%) |
| Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | 42/52 (80.8%) | 12/52 (23.1%) | 42/52 (80.8%) |
| Event | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) |
|---|---|---|
| HyponatremiaMetabolism and nutrition disorders | 0/54 | 4/52 |
| Death NOSGeneral disorders | 4/54 | 2/52 |
| SepsisInfections and infestations | 3/54 | 1/52 |
| HypokalemiaMetabolism and nutrition disorders | 1/54 | 2/52 |
| Platelet count decreasedInvestigations | 0/54 | 2/52 |
| HypotensionVascular disorders | 2/54 | 0/52 |
| Alanine aminotransferase increasedInvestigations | 1/54 | 1/52 |
| ApneaRespiratory, thoracic and mediastinal disorders | 0/54 | 1/52 |
| Catheter related infectionInfections and infestations | 0/54 | 1/52 |
| DiarrheaGastrointestinal disorders | 0/54 | 1/52 |
| Event | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) |
|---|---|---|
| Neutrophil count decreasedInvestigations | 19/54 | 24/52 |
| Platelet count decreasedInvestigations | 15/54 | 19/52 |
| DiarrheaGastrointestinal disorders | 13/54 | 15/52 |
| White blood cell decreasedInvestigations | 13/54 | 15/52 |
| Lymphocyte count decreasedInvestigations | 9/54 | 10/52 |
| AnemiaBlood and lymphatic system disorders | 10/54 | 7/52 |
| VomitingGastrointestinal disorders | 7/54 | 2/52 |
| Febrile neutropeniaBlood and lymphatic system disorders | 5/54 | 6/52 |
| DehydrationMetabolism and nutrition disorders | 6/54 | 4/52 |
| HypokalemiaMetabolism and nutrition disorders | 6/54 | 3/52 |
| Age, Categorical(Participants) | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | Total |
|---|---|---|---|
| <=18 years | 51 | 49 | 100 |
| Between 18 and 65 years | 4 | 4 | 8 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | Total |
|---|---|---|---|
| Mean | 9.82 ± 5.29 | 10.25 ± 4.91 | 10.03 ± 5.09 |
| Sex: Female, Male(Participants) | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | Total |
|---|---|---|---|
| Female | 21 | 16 | 37 |
| Male | 34 | 37 | 71 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 10 | 19 |
| Not Hispanic or Latino | 45 | 43 | 88 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 8 | 6 | 14 |
| White | 41 | 42 | 83 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(participants) | Arm I (Temozolomide, Irinotecan Hydrochloride) | Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab) | Total |
|---|---|---|---|
| United States | 45 | 43 | 88 |
| Canada | 7 | 7 | 14 |
| Australia | 3 | 2 | 5 |
| New Zealand | 0 | 1 | 1 |
Showing the first 100 of 158 sites across 5 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Irinotecan · Temozolomide
National Cancer Institute (NCI) →