Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Adult Glioblastoma

Adult Giant Cell Glioblastoma

Adult Gliosarcoma

Treatments

Drug: carboxyamidotriazole

Other: pharmacological study

Radiation: radiation therapy

Study type

Interventional

Funder types

NIH

Identifiers

NCT00004146

NABTT-9904 (Other Identifier)

CDR67378

U01CA062475 (U.S. NIH Grant/Contract)

NCI-2012-03011 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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