Know Cancer

or
forgot password

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 CenterBronx, New York  10461
Kaplan Cancer CenterNew York, New York  10016
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, 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 AssociationPeoria, Illinois  61602
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Beckman Research Institute, City of HopeLos Angeles, California  91010
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
CCOP - EvanstonEvanston, Illinois  60201
Veterans Affairs Medical Center - New YorkNew York, New York  10010
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - ClevelandCleveland, Ohio  44106
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
CCOP - Sooner StateTulsa, Oklahoma  74136
Veterans Affairs Medical Center - GainsvilleGainesville, Florida  32608-1197
Allegheny UniversityPhiladelphia, Pennsylvania  19146