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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
Sponsor:
Information provided by:
University of New Mexico

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

Resource links provided by the National Library of Medicine


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, Older Adult)
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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Information from the National Library of Medicine

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


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    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