Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00027612
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Irinotecan may make the tumor cells more sensitive to radiation therapy. PURPOSE: This phase I/II trial is studying the side effects of irinotecan given together with radiation therapy followed by irinotecan and carmustine and to see how well it works in treating patients with newly-diagnosed glioblastoma multiforme.

Key Dates

Start date
Jul 31, 2002
Status verified
Dec 2016
Primary completion
Oct 31, 2006
Completion
Jul 31, 2009

Study Design

Enrollment
58 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan + carmustine and radiation
    Phase II (patients receiving concurrent EIACs or non-EIACs open to accrual as of 3/5/2005): Patients receive irinotecan at the recommended dose, carmustine, and cranial irradiation as in phase I. Patients with disease progression are followed every 3 months for 5 years and then annually for up to 10 years. Patients taken off study for reasons other than disease progression are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

Primary Outcome Measure

Survival at 52 weeks [ Time Frame: at 52 weeks ]

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