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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: 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.


Original Primary Outcome: Overall survival

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Response rate for each treatment arm
  • Event-free survival (time from enrollment to disease progression, second malignant neoplasm, death regardless of cause, or date of last contact)


Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 7, 2010
Date Started: November 2010
Date Completion:
Last Updated: May 18, 2017
Last Verified: May 2017