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

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00251797
First received: November 8, 2005
Last updated: January 6, 2010
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Brain and Nervous System
Cancer
 Drug: Irinotecan
Drug: Thalidomide
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors.

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Tolerable dosage of thalidomide in combination with irinotecan [ Time Frame: Unacceptable toxicities ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: March 2000
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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
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)?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dennie Jones, MD, University of New Mexico CRTC
ClinicalTrials.gov Identifier: NCT00251797     History of Changes
Other Study ID Numbers: 2799C
Study First Received: November 8, 2005
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

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
Thalidomide
Irinotecan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013