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


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Friedland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000067636

NCT ID:

NCT00005045

Start Date:

March 2000

Completion Date:

June 2004

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

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