Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.

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

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Interferon-alpha; Interferons; Tretinoin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic renal cell carcinoma

• Bidimensionally measurable disease

• No active brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

• No coagulation disorders

Hepatic:

• Bilirubin less than 1.5 mg/dL

• SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal

• No clinically significant hepatic disease, including autoimmune hepatitis

Renal:

• Creatinine less than 2 mg/dL OR

• Creatinine clearance greater than 50 mL/min

• No clinically significant renal disease

Cardiovascular:

• No clinically significant cardiac disease

• No thrombophlebitis

Pulmonary:

• No severe debilitating pulmonary disease

• No pulmonary embolism

Other:

• No history of diabetes mellitus prone to ketoacidosis

• No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study

• No thyroid abnormalities that hinder maintaining thyroid function at the normal range

• No severe infection

• No severe malnutrition

• No clinically significant retinal abnormalities

• No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder

• No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No more than 1 prior biological response modifier therapy or immunotherapy

Chemotherapy:

• No more than 1 prior chemotherapy regimen

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• At least 4 weeks since prior major surgery

Other:

• No prior retinoid therapy