Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Tretinoin Plus Interferon alfa in Treating Patients With Metastatic Kidney Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Other NYWCCC-0498-209 NCI-V98-1490, NCT00003656

Objectives

1. Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b.
2. Determine the toxicity of this regimen in these patients.
3. Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies.

Entry Criteria

Disease Characteristics:

• Histologically confirmed metastatic renal cell carcinoma



• Bidimensionally measurable disease



• No active brain metastases

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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.

Outcomes

Response as measured by CT, bone scans, and clinical progression at 8 weeks after first dose
Toxicity by clinical evaluation from first dose to 30 days after last dose

Retinoic acid receptor expression on tissue as measured by the presence of peripheral blood lymphocytes during the first and fifth dose
Duration of response (progression-free survival) as measured by CT, bone scans, and clinical progression from initiation of therapy until an increase of ≥ 25% from the smallest sum of all tumor measurements obtained during the best response

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.

Goldberg JS, Vargas M, Rosmarin AS, et al.: Phase I trial of interferon alpha2b and liposome-encapsulated all-trans retinoic acid in the treatment of patients with advanced renal cell carcinoma. Cancer 95 (6): 1220-7, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

New York Weill Cornell Cancer Center at Cornell University

David Nanus, MD, Protocol chair		Ph: 212-746-2920 Email: dnanus@med.cornell.edu

Registry Information
Official Title		Phase II Trial of Atragen and Interferon Alfa-2b in Patients with Advanced Renal Cell Carcinoma
Trial Start Date		1999-01-19
Registered in ClinicalTrials.gov		NCT00003656
Date Submitted to PDQ		1998-11-06
Information Last Verified		2006-05-02

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