Kidney Cancer Clinical Trial
Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney 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.
Full Description
OBJECTIVES:
Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b.
Determine the toxicity of this regimen in these patients.
Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies.
OUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.)
Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined additional patients are accrued and treated at that dose. (Phase I closed to accrual as of 9/24/03.)
During the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. After week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.)
Patients are followed at 30 days after the last treatment.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued into the phase II portion of this study.
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
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There are 2 Locations for this study
New York New York, 10021, United States
New York New York, 10032, United States
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