A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors
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ClinicalTrials.gov Identifier: NCT00251797 |
Recruitment Status
:
Completed
First Posted
: November 10, 2005
Last Update Posted
: January 7, 2010
|
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The study will try to answer these questions:
- What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan?
- How well does this combination work to shrink brain tumors, and how long do responses to treatment last?
- What side effects does the combination of drugs cause?
- How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Nervous System Cancer | Drug: Irinotecan Drug: Thalidomide | Phase 1 |
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:
- What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan?
- How well does this combination work to shrink brain tumors, and how long do responses to treatment last?
- What side effects does the combination of drugs cause?
- How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors. |
Study Start Date : | March 2000 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |
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Drug: Irinotecan
- Tolerable dosage of thalidomide in combination with irinotecan [ Time Frame: Unacceptable toxicities ]
- Tumor response. For this study, the definition of response will include complete response, partial response and stable disease. Duration of tumor response. uality of life while on treatment [ Time Frame: unacceptable toxicities ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 tumors.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251797
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 |
Principal Investigator: | Dennie Jones, MD | University of New Mexico |
Responsible Party: | Dennie Jones, MD, University of New Mexico CRTC |
ClinicalTrials.gov Identifier: | NCT00251797 History of Changes |
Other Study ID Numbers: |
2799C |
First Posted: | November 10, 2005 Key Record Dates |
Last Update Posted: | January 7, 2010 |
Last Verified: | October 2008 |
Keywords provided by University of New Mexico:
Phase I Brain cancer Recurrent CNS tumors |
Additional relevant MeSH terms:
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Irinotecan Camptothecin Thalidomide Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |