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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Temozolomide — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Nov 22, 2010

Status verified

Jun 2021

Primary completion

Dec 31, 2017

Completion

Jun 30, 2021

Study Design

Enrollment

108 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (temozolomide, irinotecan hydrochloride)
  Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.
• 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.

Primary Outcome Measure

Overall Survival [ Time Frame: Up to 5 years after enrollment ]

Locations (136)

Find similar trials in Birmingham, AL

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