Phase 2
Completed N=55
Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM
Adult Giant Cell Glioblastoma · Adult Glioblastoma · Adult Gliosarcoma
Source: ClinicalTrials.gov NCT00004146 ↗
Enrolled (actual)
55
Serious AEs
12.7%
Results posted
May 2015
Primary outcomePrimary: Overall Survival Rate — 10.3 months — p=0.10
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Rate |
10.3 | 0.10 |
| PRIMARY Toxicity of CAI When Combined With RT |
16 | — |
| PRIMARY Correlation Between PK CAI and Toxicity in This pt Population |
1.3; 4.06 | — |
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 = = 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
Data sourced from ClinicalTrials.gov (NCT00004146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.