Carboxyamidotriazole in Treating Patients With Advanced Kidney Cancer

June 20, 2013 updated by: Eastern Cooperative Oncology Group

Phase II Study of Carboxyamidotriazole (CAI, NSC #609974) in Patients With Advanced Renal Cell Carcinoma Refractory to Immunotherapy

RATIONALE: Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have advanced kidney cancer that has not responded to biological therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OBJECTIVES: I. Determine the disease free progression at 6 months in patients with locally recurrent or metastatic renal cell cancer (refractory to immunotherapy) treated with carboxyamidotriazole. II. Evaluate the progression free survival rate and response rate in these patients on this regimen. III. Evaluate the toxic effect of this regimen on these patients.

OUTLINE: Patients receive oral carboxyamidotriazole daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease may discontinue therapy after 6 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and every 12 months thereafter until death.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 20 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927-5800
        • MBCCOP - San Juan
      • San Juan, Puerto Rico, 00927-5800
        • Veterans Affairs Medical Center - San Juan
  • South Africa
      • Pretoria, South Africa, 0001
        • Pretoria Academic Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • California
      • Los Angeles, California, United States, 91010
        • Beckman Research Institute, City of Hope
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Medical Center - Palo Alto
      • Stanford, California, United States, 94305-5408
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80209-5031
        • CCOP - Colorado Cancer Research Program, Inc.
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5000
        • Walter Reed Army Medical Center
    • Florida
      • Gainesville, Florida, United States, 32608-1197
        • Veterans Affairs Medical Center - Gainsville
      • Miami, Florida, United States, 33136
        • Sylvester Cancer Center, University of Miami
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
      • Tampa, Florida, United States, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
      • Decatur, Georgia, United States, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
    • Illinois
      • Evanston, Illinois, United States, 60201
        • CCOP - Evanston
      • Peoria, Illinois, United States, 61602
        • CCOP - Illinois Oncology Research Association
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5265
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Medical Center
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute Of New Jersey
    • New York
      • Albany, New York, United States, 12208
        • Veterans Affairs Medical Center - Albany
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center
      • Brooklyn, New York, United States, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • New York, New York, United States, 10016
        • Kaplan Cancer Center
      • New York, New York, United States, 10010
        • Veterans Affairs Medical Center - New York
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Veterans Affairs Medical Center - Cleveland
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • CCOP - Sooner State
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinical and Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19102-1192
        • Hahnemann University Hospital
      • Philadelphia, Pennsylvania, United States, 19146
        • Allegheny University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Cancer Institute
      • Pittsburgh, Pennsylvania, United States, 15240
        • Veterans Affairs Medical Center - Pittsburgh
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105-1080
        • CCOP - Sioux Community Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven advanced renal cell cancer Locally recurrent or metastatic lesions not amenable to current resection Progressive disease defined as 25% increase from last measurement or new lesions Bidimensionally measurable disease No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 OR Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT and/or SGPT less than 2 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious medical illness or active infection that would preclude chemotherapy compliance No other prior malignancy unless curatively treated and disease free for the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy At least 1 (but no more than 2) prior biologic regimen(s) (i.e., interleukin-2, interferon alfa, or combination) and recovered Regimen defined as at least 8 weeks of treatment Prior sargramostim allowed Chemotherapy: No prior chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy (i.e., megestrol or tamoxifen) and recovered Radiotherapy: No prior radiotherapy to study lesions At least 4 weeks since prior radiotherapy and recovered No concurrent palliative radiotherapy Surgery: Prior nephrectomy allowed Recovered from any recent surgery

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eastern Cooperative Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: David Friedland, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2000

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2000

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDR0000067636
  • ECOG-4896

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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