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Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Study Purpose

RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment. PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.

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 malignant glioma of 1 of the following subtypes: - Low-grade glioma.
  • - Anaplastic astrocytoma.
  • - Anaplastic oligodendroglioma.
  • - Glioblastoma multiforme.
  • - Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy.
  • - Scheduled to undergo surgical resection.
  • - Able to undergo maximal surgical resection of tumor mass.
PATIENT CHARACTERISTICS:
  • - Karnofsky performance status 70-100% - Mini Mental Status Exam ≥ 15.
  • - Absolute neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Creatinine ≥ 1.7 mg/dL.
  • - BUN ≤ 2 times upper limit of normal (ULN) - Transaminases ≤ 4 times ULN.
  • - Not pregnant or nursing.
  • - Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment.
  • - No other medical illness that would preclude study treatment, including any of the following: - Serious infection.
  • - Uncontrolled hypertension.
  • - Unstable angina pectoris.
  • - Uncontrolled cardiac dysrhythmia.
PRIOR CONCURRENT THERAPY:
  • - See Disease Characteristics.
  • - Recovered from all prior therapy.
  • - At least 4 weeks since prior investigational drugs.
  • - No more than 1 prior chemotherapy regimen.
  • - No concurrent chemotherapy, biologic therapy, or radiotherapy.
- No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system

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.

 NCT00401024
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.

 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

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

 Stuart A. Grossman, MD
Principal Investigator Affiliation Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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: Primary.

  • - Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic tumor:plasma concentration ratio, in patients with primary malignant glioma.
Secondary.
  • - Correlate tumor grade (low vs.#46;high) and/or tumor enhancement on MRI with tumor concentration of this drug in these patients.
, OUTLINE: Patients receive oral imatinib mesylate once daily for 7-12 days. Patients then undergo surgical resection. Blood and tissue samples are collected at the time of surgery and analyzed for imatinib mesylate concentration. After completion of study treatment, patients are followed for 7 days. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Arms & Interventions

Arms

Experimental: Treatment

Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery

Interventions

Drug: - imatinib mesylate

Other: - pharmacological study

Procedure: - conventional surgery

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.

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410

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