A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT00251797
Phase
PHASE1
Status
Completed

Conditions

  • Brain and Nervous System
  • Cancer

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    Irinotecan: 300 to 350 mg/m2 mixing with 250 cc. Dextrose injection. IV infusion over 90 minutes D1 and repeat every 21 days
  • Thalidomide — DRUG
    Thalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle

Study Details

The study will try to answer these questions: 1. What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan? 2. How well does this combination work to shrink brain tumors, and how long do responses to treatment last? 3. What side effects does the combination of drugs cause? 4. How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?

Key Dates

Start date
Mar 31, 2000
Status verified
Oct 2008
Primary completion
Jun 30, 2006
Completion
Jun 30, 2006

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Tolerable dosage of thalidomide in combination with irinotecan [ Time Frame: Unacceptable toxicities ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of New MexicoAlbuquerqueNew Mexico87131-

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