Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

New York Weill Cornell Cancer Center at Cornell University

David M. Nanus, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003656
Information obtained from ClinicalTrials.gov on January 10, 2012

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