Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM

NCT00004146 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2012-03011CDR67378NABTT-9904U01CA062475
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma

Outcome Measures

Primary Outcomes (3)

• Overall Survival Rate

  estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death

  approximately 30 months

• Toxicity of CAI When Combined With RT

  patients who experienced a grade 3 or higher event considered at least possibly related to CAI

  pts were reviewed for toxicity while on treatement - median time of 2 months

• Correlation Between PK CAI and Toxicity in This pt Population

  PK paramenters including steady state CAI concentrations with toxicity/or drug activity

  during treatment

Study Arms (1)

Treatment (RT and CAI)

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

Radiation: radiation therapy; Drug: carboxyamidotriazole; Other: pharmacological study

Interventions

radiation therapy RADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (RT and CAI)

carboxyamidotriazole DRUG

Given orally

Also known as: CAI, carboxyamido-triazole, carboxyaminoimidazole

Treatment (RT and CAI)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (RT and CAI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (8)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

University of Pennsylavania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

Radiotherapy; Radiation; carboxyamido-triazole

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Stuart A Grossman
• Organization: Adult Brain Tumor Consortium

jfisher@jhmi.edu

410-955-3657

Study Officials

• Tom Mikkelsen, MD

  New Approaches to Brain Tumor Therapy Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: June 4, 2004
• Study Start: March 1, 2000
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 8, 2015
• Results First Posted: May 8, 2015

Record last verified: 2015-04

Locations

US (8)