Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: recombinant interferon alfa; tretinoin liposome
Intervention MeSH terms: Interferons; Interferon-alpha; Tretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV renal cell cancer; recurrent renal cell cancer

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.
    

Eligibility 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