Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carboxyamido-triazole

Criteria

Inclusion Criteria:

• Histologically confirmed renal cell carcinoma

• Metastatic or unresectable disease

• Documented disease progression, even after nephrectomy

• At least 1 unidimensionally measurable lesion

• At least 20 mm by conventional techniques

• At least 10 mm by spiral CT scan

• The following lesions are not considered measurable:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Abdominal masses not confirmed and followed by imaging

• Cystic lesions

• Performance status - CTC 0-2

• WBC at least 2,000/mm^3

• Platelet count at least 75,000/mm^3

• Bilirubin no greater than upper limit of normal (ULN)

• AST no greater than 2.5 times ULN

• Creatinine no greater than 2.0 mg/dL

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No baseline neuropathy or cerebellar dysfunction greater than grade 1

• At least 4 weeks since prior immunotherapy

• No prior carboxyamidotriazole

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

• Concurrent epoetin alfa allowed

• At least 4 weeks since prior chemotherapy

• No concurrent chemotherapy

• No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes)

• At least 4 weeks since prior radiotherapy

• No concurrent palliative radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior surgery