Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors
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|ClinicalTrials.gov Identifier: NCT01217437|
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : September 13, 2019
Last Update Posted : July 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Neoplasm Pineoblastoma Recurrent Medulloblastoma Recurrent Primitive Neuroectodermal Tumor Refractory Medulloblastoma Refractory Peripheral Primitive Neuroectodermal Tumor||Biological: Bevacizumab Drug: Irinotecan Hydrochloride Drug: Temozolomide||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Temozolomide With Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, a COG Randomized Phase II Screening Trial|
|Actual Study Start Date :||November 22, 2010|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||June 30, 2021|
Experimental: Arm I (temozolomide, irinotecan hydrochloride)
Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.
Drug: Irinotecan Hydrochloride
Experimental: Arm II (temozolomide, irinotecan hydrochloride, bevacizumab)
Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
Drug: Irinotecan Hydrochloride
- Overall Survival [ Time Frame: Up to 5 years after enrollment ]Percentage Probability of remaining alive 5 years after enrollment estimated by the method of Kaplan and Meier
- Response [ Time Frame: Up to 12 cycles of therapy (11 months) ]Patient's best response during protocol therapy coded as complete response, partial response or no response.
- Event-free Survival [ Time Frame: Up to 5 years after enrollment ]Percentage Probability of remaining event-free 5 years after enrollment estimated by the method of Kaplan and Meier
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217437
|Principal Investigator:||Adam S Levy||Children's Oncology Group|