Carboxyamidotriazole in Treating Patients With Advanced Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: carboxyamidotriazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboxyamidotriazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer