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

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