CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
carboxyamidotriazole +2 moredrug
Likely dose
Carboxyamidotriazole (CAI) given orallyAI-extracted
Key inclusion· 7
  • Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
  • Measurable or non-measurable tumor on post-operative, pretreatment MRI/CT within 2 weeks of starting treatment
  • No prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy, biologic agents, immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK, or gene therapy for brain tumor (glucocorticoids allowed)
  • Recovered from immediate post-operative period and maintained on stable steroid regimen (no increase for last 5 days)
Key exclusion· 2
  • Prior therapy for brain tumor except surgery
  • Prior treatment with antineoplastic agents, including CAI

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00004146
NCT00004146Phase 2Completed

Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-Amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme

National Cancer Institute (NCI)·interventional·Posted Jun 4, 2004·Updated May 8, 2015

In Brief

A Phase 2 clinical trial evaluating radiation therapy, carboxyamidotriazole, and 1 other intervention for Adult Giant Cell Glioblastoma and 2 related conditions. Completed, enrolled 55 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 4, 2004
Enrollment StartMar 1, 2000
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 22.1 years ago

Interventions

radiation therapyradiation

Undergo radiotherapy

carboxyamidotriazoledrug

Given orally

pharmacological studyother

Correlative studies