Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM

NCT ID: NCT00004146

Last Updated: 2015-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2010-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

Undergo radiotherapy

carboxyamidotriazole

Intervention Type: DRUG

Given orally

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

radiation therapy

Undergo radiotherapy

Intervention Type: RADIATION

carboxyamidotriazole

Given orally

Intervention Type: DRUG

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

irradiation; radiotherapy; therapy, radiation; CAI; carboxyamido-triazole; carboxyaminoimidazole; pharmacological studies

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Mikkelsen, MD

Role: PRINCIPAL_INVESTIGATOR

New Approaches to Brain Tumor Therapy Consortium

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

Wake Forest University

Winston-Salem, North Carolina, United States

University of Pennsylavania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

NCI-2012-03011

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR67378

Identifier Type: -

Identifier Source: secondary_id

NABTT-9904

Identifier Type: OTHER

Identifier Source: secondary_id

NABTT-9904

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA062475

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-03011

Identifier Type: -

Identifier Source: org_study_id