Bevacizumab and Irinotecan in Treating Young Patients With Recurrent, Progressive, or Refractory Glioma, Medulloblastoma, Ependymoma, or Low Grade Glioma

Conditions

• Childhood Cerebral Anaplastic Astrocytoma
• Childhood Oligodendroglioma
• Childhood Spinal Cord Neoplasm
• Recurrent Childhood Brain Stem Glioma
• Recurrent Childhood Ependymoma
• Recurrent Childhood Medulloblastoma

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Fludeoxyglucose F-18 — RADIATION
  Undergo fludeoxyglucose F18 PET
• Irinotecan Hydrochloride — DRUG
  Given IV

Study Details

This phase II trial is studying how well giving bevacizumab together with irinotecan works in treating young patients with recurrent, progressive, or refractory glioma, medulloblastoma, ependymoma, or low grade glioma. 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. Bevacizumab may also stop the growth of glioma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumor cells.

Key Dates

Start date

Aug 31, 2006

Status verified

Oct 2017

Primary completion

Oct 31, 2015

Completion

Oct 31, 2015

Study Design

Enrollment

97 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm I
  Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and irinotecan hydrochloride IV over 90 minutes on day 16 or 17 for course 1. Patients receive bevacizumab and irinotecan hydrochloride on days 1 and 15 for all subsequent courses. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients undergo MRIs of the brain, magnetic resonance perfusion/diffusion, and fludeoxyglucose F 18 positron emission tomography at baseline and periodically during treatment.

Primary Outcome Measure

Objective Response Rate Sustained for ≥ 8 Weeks [ Time Frame: From day 1 of treatment up to 24 weeks ]

Locations (11)

Find similar trials in San Francisco, CA

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