Chemotherapy in Treating Patients With Advanced Kidney Cancer

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have advanced kidney cancer.

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

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fenretinide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma

• Measurable disease

• At least 20 mm with conventional techniques OR

• At least 10 mm with spiral CT scan

• No nonmeasurable disease only including:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Lymphangitis cutis/pulmonis

• Abdominal masses not confirmed and followed by imaging techniques

• Cystic lesions

• No known brain metastases

• History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy:

• More than 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• AST no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2 mg/dL OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide

• No other concurrent uncontrolled illness (e.g., ongoing or active infection)

• No concurrent psychiatric illness or social situation that would preclude study

• History of HIV allowed if no active infection or history of retinitis

• No history of retinal disease, night blindness, or difficulty seeing in the dark

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior biologic therapy allowed

Chemotherapy:

• No more than 1 prior chemotherapy regimen

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics

Other:

• Recovered from prior therapy

• No prior systemic retinoid therapy

• No concurrent antioxidants (e.g., ascorbic acid or vitamin E)

• No other concurrent therapy for renal cell carcinoma