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

NCT00251797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-01-07

No results posted yet for this study

Summary

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)?

Conditions

  • Brain and Nervous System
  • Cancer

Interventions

DRUG

Irinotecan

Irinotecan: 300 to 350 mg/m2 mixing with 250 cc. Dextrose injection. IV infusion over 90 minutes D1 and repeat every 21 days

DRUG

Thalidomide

Thalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Dennie Jones, MD · University of New Mexico

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251797 on ClinicalTrials.gov