A Phase II Study of Temozolomide plus Irinotecan with or without Bevacizumab in Children with Recurrent or Refractory Medulloblastoma or PNET

Protocol
11-089
Full Title
Temozolomide with Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865, BB-IND# 7921) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial (COG-ACNS0821)
Phase
II
Purpose

Medulloblastoma and primitive neuroectodermal tumors (PNET) of the central nervous system are challenging to treat. Therapy may consist of a combination of surgery, chemotherapy, and/or radiation therapy, but these tumors often return or persist despite treatment.

Some patients have done better than expected with the drugs temozolomide and irinotecan. In this Children’s Oncology Group study, researchers are evaluating temozolomide and irinotecan in patients with medulloblastoma or PNET whose tumors have returned or persisted despite therapy.

Some patients will also receive bevacizumab, a drug that works by inhibiting the growth of the blood vessels that tumors need to grow and spread. Investigators will also see how well patients fare when they receive temozolomide, irinotecan, and bevacizumab. Patients will be randomly assigned to receive the two-drug regimen or the three-drug regimen.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of medulloblastoma or PNET that has returned or persisted despite therapy.
  • Patients with relapsed disease must have had at least one but no more than two recurrences.
  • Patients must have recovered from the side effects of prior therapies.
  • Patients must be age 21 or younger.

For more information about this study and to inquire about eligibility, please contact Dr. Kevin De Braganca at 212-639-3449.

Disease(s)
Pediatric Brain Tumors: Brain Cancer
Locations
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