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Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

Study Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.

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 recurrent primary malignant glioma.
  • - Anaplastic astrocytoma.
  • - Glioblastoma multiforme.
  • - Anaplastic oligodendroglioma.
  • - Gliosarcoma.
  • - Anaplastic mixed oligoastrocytoma.
  • - Measurable disease by MRI or CT.
  • - No immediate radiotherapy required.
  • - Neurologically stable for at least 2 weeks prior to study.
PATIENT CHARACTERISTICS: Age:
  • - 18 and over.
Performance status:
  • - Karnofsky 60-100% Life expectancy: - Greater than 12 weeks.
Hematopoietic:
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
  • - Hemoglobin at least 10 g/dL.
Hepatic:
  • - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT and SGPT less than 2.5 times ULN.
  • - Alkaline phosphatase less than 2 times ULN.
Renal:
  • - Blood urea nitrogen and creatinine less than 1.5 times ULN.
Other:
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - HIV negative.
  • - No other nonmalignant systemic disease.
  • - No acute infection treated with IV antibiotics.
  • - No frequent vomiting or other condition that would preclude oral medication administration (e.g., partial bowel obstruction) - No other prior malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell skin cancer.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - No more than 1 prior biologic therapy regimen.
Chemotherapy:
  • - No more than 1 prior chemotherapy regimen.
  • - At least 6 weeks since prior chemotherapy, unless evidence of disease progression.
  • - No prior failure of irinotecan or temozolomide.
Endocrine therapy:
  • - Concurrent corticosteroids allowed.
Radiotherapy:
  • - See Disease Characteristics.
  • - At least 6 weeks since prior radiotherapy, unless evidence of disease progression.
Surgery:
  • - At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered.
Other: - No concurrent immunosuppressive agents

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.

 NCT00005951
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 1
Lead Sponsor

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

 Duke University
Principal Investigator

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

 Henry S. Friedman, MD
Principal Investigator Affiliation Duke Cancer Institute
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 maximum tolerated dose of irinotecan administered in combination with temozolomide in patients with recurrent primary malignant glioma.
  • - Determine the toxicity of this combination therapy in these patients.
OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs.#46;other anticonvulsants or none). Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral temozolomide on days 1-5. Treatment continues every 43 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: Not specified

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.

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710

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