Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004146
First received: December 10, 1999
Last updated: May 5, 2015
Last verified: April 2015

December 10, 1999
May 5, 2015
March 2000
January 2010   (final data collection date for primary outcome measure)
  • Overall Survival Rate [ Time Frame: approximately 30 months ] [ Designated as safety issue: Yes ]
    estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death
  • Toxicity of CAI When Combined With RT [ Time Frame: pts were reviewed for toxicity while on treatement - median time of 2 months ] [ Designated as safety issue: Yes ]
    patients who experienced a grade 3 or higher event considered at least possibly related to CAI
  • Correlation Between PK CAI and Toxicity in This pt Population [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
    PK paramenters including steady state CAI concentrations with toxicity/or drug activity
Not Provided
Complete list of historical versions of study NCT00004146 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM
Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-Amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Radiation: radiation therapy
    Undergo radiotherapy
    Other Names:
    • irradiation
    • radiotherapy
    • therapy, radiation
  • Drug: carboxyamidotriazole
    Given orally
    Other Names:
    • CAI
    • carboxyamido-triazole
    • carboxyaminoimidazole
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
Experimental: Treatment (RT and CAI)

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

Interventions:
  • Radiation: radiation therapy
  • Drug: carboxyamidotriazole
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
January 2010
January 2010   (final data collection date for primary outcome measure)

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

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004146
NCI-2012-03011, NCI-2012-03011, CDR67378, NABTT-9904, NABTT-9904, U01CA062475
Yes
Not Provided
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Tom Mikkelsen, MD New Approaches to Brain Tumor Therapy Consortium
National Cancer Institute (NCI)
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP