NCT01217437

Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Central Nervous System Neoplasm
• Pineoblastoma
• Recurrent Medulloblastoma
• Recurrent Primitive Neuroectodermal Tumor
• Refractory Medulloblastoma
• Refractory Peripheral Primitive Neuroectodermal Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
DRUG	Irinotecan Hydrochloride	Given IV
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2010-11-22
• Primary completion: 2017-12-31
• Completion: 2021-06-30
• First posted: 2010-10-08
• Last updated: 2021-07-23
• Results posted: 2019-09-13

Locations

158 sites across 5 countries: United States, Australia, Canada, New Zealand, Puerto Rico