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Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy

Study Purpose

RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed glioblastoma multiforme (GBM) - Recurrent disease allowed.
  • - Evaluable disease on contrast-enhanced MRI.
  • - Prior external beam radiotherapy required.
PATIENT CHARACTERISTICS: Age:
  • - 18 and over.
Performance status:
  • - Karnofsky 60-100% Life expectancy: - Not specified.
Hematopoietic:
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
Hepatic:
  • - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST or ALT no greater than 5 times ULN.
Renal:
  • - Creatinine no greater than 1.5 times ULN OR.
  • - Creatinine clearance at least 60 mL/min.
Cardiovascular:
  • - No significant cardiac disease.
  • - No uncontrolled high blood pressure.
  • - No unstable angina.
  • - No congestive heart failure.
  • - No myocardial infarction within the past 3 months.
  • - No serious cardiac arrhythmias.
Gastrointestinal:
  • - Able to take oral medication.
  • - No gastrointestinal abnormalities.
  • - No requirement for IV alimentation.
  • - No active peptic ulcer disease.
Other:
  • - No active infection.
  • - No serious uncontrolled medical disorder.
  • - No dementia or significantly altered mental status that would preclude study.
  • - No known hypersensitivity to irinotecan or thalidomide.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - No prior thalidomide.
Chemotherapy:
  • - No prior irinotecan.
  • - At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse) Endocrine therapy: - Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study.
  • - No concurrent hormonal therapy for GBM.
Radiotherapy:
  • - See Disease Characteristics.
  • - No concurrent radiotherapy for GBM.
Surgery:
  • - No prior surgical procedures affecting absorption.
Other:
  • - No other concurrent anticancer investigational agents for GBM.
  • - No concurrent cytochrome P450 inhibitors, including the following: - Nefazodone.
  • - Fluvoxamine.
  • - Fluoxetine.
  • - Sertraline.
  • - Paroxetine.
  • - Venlafaxine.
  • - Ketoconazole.
  • - Itraconazole.
  • - Fluconazole.
  • - Cimetadine.
  • - Clarithromycin.
  • - Diltiazem.
  • - Erythromycin.
- Protease inhibitors

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00039468
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Dartmouth-Hitchcock Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Camilo E. Fadul, MD
Principal Investigator Affiliation Norris Cotton Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Determine the response rate of patients with glioblastoma multiforme treated with thalidomide and irinotecan after radiotherapy.
  • - Determine the preliminary efficacy of this regimen in these patients.
  • - Determine the disease-free survival and overall survival of patients treated with this regimen.
  • - Determine the toxicity of this regimen in these patients.
  • - Assess the quality of life of patients treated with this regimen.
OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6. Patients are followed for 5 years. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lebanon, New Hampshire

Status

Address

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002

Columbus, Ohio

Status

Address

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240

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