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

Phase 1
18 Years
Not Enrolling
Brain and Nervous System, Cancer

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Trial Information

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

This is a Phase I study, which means these trials are generally comparatively small and are
used to determine toxicity and maximum dose. Currently, there are no "standard" treatments
for Recurrent CNS Tumors. In this study, approximately 14 patients with Recurrent CNS Tumors
will receive treatment with irinotecan, an intravenous drug, and thalidomide, a drug taken
by mouth. Both have been approved by the Federal Food and Drug Administration as treatments
for cancer, but they have not been tested together for brain cancer.

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)?

Inclusion Criteria:

- Biopsy proven high grade astrocytomas, glioblastoma multiforme, anaplastic
astrocytoma, anaplastic oligodendroglioma, mixed oligodendroglioma.

- Subjects are allowed to have definitive surgery and/or radiation treatment to their

- Subjects are allowed to have previous chemotherapy for their tumors.

- Subjects who previous diagnosed to have a low grade lesion need a second biopsy to
show transformation into a high grade histology.

- Subjects need to have radiographic or biopsy proven recurrent disease.

- ECORT performance status 2 or lower. See appendix I.

- Baseline laboratory values within 30 days of study entry: hemoglobin 10 gm/dl;
absolute neutrophil count 1,500 cells/ml; platelet counts 100,000 cells/ml; SGOT/AST,
SGPT/ALT, alkaline phosphatase, LDH 3high normal limit; total bilirubin 2.0 mg/dl.

- Ability to provide written informed consent.

- Age > 18 years.

- Female patients of childbearing potential must have a documented negative serum
pregnancy test within 14 days of study entry.

- All subjects must agree to use an effective method of contraception for the duration
of treatment if engaged in sexual activity where conception is possible, as specified
in the STEP program for thalidomide.

Exclusion Criteria:

- Therapy with any investigational drug (other than drugs available on treatment IND
and used for FDA-sanctioned indications) and/or any chemotherapy regimen within 28
days of study entry.

- Prior therapy with either irinotecan or thalidomide.

- Oxygen saturation 90% on room air.

- Cardiac insufficiency at New York Heart Association status 2 or greater.

- Other active malignancies except basal or squamous cell carcinoma of the skin or in
situ cervical and breast lesions.

- History of neuropsychiatric disorder or altered mental status which prevent informed
consent or compliance with protocol requirement.

- Known hypersensitivity or allergic reaction to study drug.

- Women at any stage of pregnancy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerable dosage of thalidomide in combination with irinotecan

Outcome Time Frame:

Unacceptable toxicities

Safety Issue:


Principal Investigator

Dennie Jones, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:




Start Date:

March 2000

Completion Date:

June 2006

Related Keywords:

  • Brain and Nervous System
  • Cancer
  • Phase I
  • Brain cancer
  • Recurrent CNS tumors
  • Central Nervous System Neoplasms



University of New MexicoAlbuquerque, New Mexico  87131