Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM
Completed · Phase 2
Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
In brief
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.
Key facts
- Study ID
- NCT00004146
- Run by
- National Cancer Institute (NCI)
- People needed
- 55
- Starts
- 2000-03-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2015-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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