Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors
|Recurrent Childhood Medulloblastoma Recurrent Childhood Pineoblastoma Recurrent Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified||Biological: Bevacizumab Drug: Irinotecan Hydrochloride Drug: Temozolomide||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- Overall survival for each treatment arm [ Time Frame: Up to 5 years ]Determined for each patient and compared across regimens using the log-rank test.
- Event-free survival [ Time Frame: From enrollment to disease progression, second malignant neoplasm, death regardless of cause, or date of last contact, whichever comes first, up to 5 years ]Estimated by Kaplan-Meier method. Determined for each patient and compared across regimens using the log-rank test.
- Response rate for each treatment arm [ Time Frame: Up to 5 years ]Compared by means of the exact conditional test of proportions.
|Actual Study Start Date:||November 22, 2010|
|Estimated Primary Completion Date:||June 30, 2017 (Final data collection date for primary outcome measure)|
Experimental: Arm I (temozolomide, irinotecan hydrochloride)
Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.
Drug: Irinotecan Hydrochloride
Other Names:Drug: Temozolomide
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.
Other Names:Drug: Irinotecan Hydrochloride
Other Names:Drug: Temozolomide
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217437
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|Principal Investigator:||Adam Levy||Children's Oncology Group|