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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
Not Enrolling
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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David Friedland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




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



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