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

Study Description

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Brief 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)?

Condition or disease	Intervention/treatment	Phase
Brain and Nervous System; Cancer	Drug: Irinotecan; Drug: Thalidomide	Phase 1

Detailed Description:

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)?

Study Design

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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

Arms and Interventions

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Intervention Details:

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
Other Name: Camptosar
Drug: Thalidomide
Thalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle
Other Name: Thalomid

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Locations

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:	Dennie Jones, MD	University of New Mexico

More Information

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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
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