Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT00389584
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors
  • Cognitive/Functional Effects
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Poor Performance Status
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
1 Year - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • irinotecan hydrochloride — DRUG
  • cognitive assessment — PROCEDURE
  • management of therapy complications — PROCEDURE
  • radiation therapy — RADIATION

Study Details

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when given together with whole-brain radiation therapy and to see how well they work in treating patients with brain metastases from solid tumors. (The study of side effects and best dose has ended as of 4/15/05)

Key Dates

Start date
Dec 31, 2002
Status verified
Oct 2017
Primary completion
Nov 30, 2006
Completion
Nov 30, 2006

Study Design

Enrollment
30 participants (actual)
Primary purpose
TREATMENT

Primary Outcome Measure

Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05)

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Cancer CenterSacramentoCalifornia95817-

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