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Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM

Study Purpose

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

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

Inclusion Criteria:

  • - Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) - Patients must have measurable or non-measurable tumor on the post operative, pretreatment MRI/CT scan (within two weeks of starting treatment) - Patients must not have received prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed.
  • - Patients must have recovered from the immediate post-operative period and be maintained on a stable steroid regimen (no increase for the last five days) - Absolute neutrophil count >= 1500/mm^3.
  • - Platelets >= 100,000/mm^3.
  • - Hemoglobin concentration >= 9.0 g/dl.
  • - Creatinine =< 1.7mg/dL.
  • - Total bilirubin =< 1.2 mg/dl.
  • - Transaminases =< 2 times above the upper limits of the institutional normal.
  • - Estimated life expectancy greater than 2 months.
  • - Patients must give informed consent and understand the investigational nature of this study and its potential risks and benefits.
  • - Patients, if female and of childbearing potential must have a negative serum beta-hCG test and must not be breast feeding; all patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception.
  • - Patients must have a Karnofsky performance status of >= 60% - No other serious concurrent infection or other medical illness should be present which would jeopardize the ability of the patient to receive the drug outlined in this protocol with reasonable safety.
  • - Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ; patients with prior malignancies must be disease-free for >= five years.

Exclusion Criteria:

  • - Patients must be able to comply with prescribed medical care.
- Prior therapy for the brain tumor (except surgery) - Prior treatment with antineoplastic agents, including CAI

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.

 NCT00004146
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.

 National Cancer Institute (NCI)
Principal Investigator

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

 Tom Mikkelsen, MD
Principal Investigator Affiliation New Approaches to Brain Tumor Therapy Consortium
Agency Class

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

 NIH
Overall Status Completed
Countries United States
Conditions

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

 Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
Additional Details

PRIMARY OBJECTIVES:

  • I. To evaluate overall survival rate in patients administered CAI (carboxyamidotriazole) and radiation therapy to adults with newly diagnosed glioblastoma multiforme.
  • II. To determine the toxicity of CAI when combined with cranial irradiation.
  • III. To estimate correlations between pharmacokinetic parameters, including steady state CAI concentration, with toxicity and/or drug activity in this patient population.
  • IV. To estimate duration of disease free progression with this treatment regime.
OUTLINE: This is a multicenter study. Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.

Arms & Interventions

Arms

Experimental: Treatment (RT and CAI)

Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival. Other: pharmacological study, radiation therapy

Interventions

Radiation: - radiation therapy

Undergo radiotherapy

Drug: - carboxyamidotriazole

Given orally

Other: - pharmacological study

Correlative studies

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.

University of Alabama Birmingham, Birmingham, Alabama

Status

Address

University of Alabama Birmingham

Birmingham, Alabama, 35294

Moffitt Cancer Center, Tampa, Florida

Status

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Atlanta, Georgia

Status

Address

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322

Johns Hopkins University, Baltimore, Maryland

Status

Address

Johns Hopkins University

Baltimore, Maryland, 21287

Henry Ford Hospital, Detroit, Michigan

Status

Address

Henry Ford Hospital

Detroit, Michigan, 48202

Wake Forest University, Winston-Salem, North Carolina

Status

Address

Wake Forest University

Winston-Salem, North Carolina, 27157

Philadelphia, Pennsylvania

Status

Address

University of Pennsylavania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

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