Completed

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

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What is being tested

radiation therapy

+ carboxyamidotriazole

+ pharmacological study

RadiationDrugOther
Who is being recruted

Astrocytoma+8

+ Glioma

+ Neoplasms

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2000
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: May 8, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2000

Actual date on which the first participant was enrolled.

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.

NCT00004146
Principal SponsorNational Cancer Institute (NCI)
Last updated: May 8, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

55 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, NeuroepithelialGlioblastomaGliosarcoma

Criteria

16 inclusion criteria required to participate
Patients must give informed consent and understand the investigational nature of this study and its potential risks and benefits
Patients must have a Karnofsky performance status of >= 60%
Platelets >= 100,000/mm^3
Estimated life expectancy greater than 2 months
Show More Criteria
3 exclusion criteria prevent from participating
Prior therapy for the brain tumor (except surgery)
Prior treatment with antineoplastic agents, including CAI
Patients must be able to comply with prescribed medical care

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

University of Alabama Birmingham

Birmingham, United StatesOpen University of Alabama Birmingham in Google Maps

Moffitt Cancer Center

Tampa, United States

Emory University/Winship Cancer Institute

Atlanta, United States

Johns Hopkins University

Baltimore, United States
Completed8 Study Centers