Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer

NCT ID: NCT00003656

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2008-05-31

Brief 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.

Detailed 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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All subjects

Weekly ATRA-IV with recombinant interferon alfa

Group Type: EXPERIMENTAL

recombinant interferon alfa

Intervention Type: BIOLOGICAL

tretinoin liposome

Intervention Type: DRUG

Interventions

recombinant interferon alfa

Intervention Type: BIOLOGICAL

tretinoin liposome

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M. Nanus, MD

Role: STUDY_CHAIR

Weill Medical College of Cornell University

Locations

New York Weill Cornell Cancer Center at Cornell University

New York, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Countries

United States

References

Goldberg JS, Vargas M, Rosmarin AS, Milowsky MI, Papanicoloau N, Gudas LJ, Shelton G, Feit K, Petrylak D, Nanus DM. Phase I trial of interferon alpha2b and liposome-encapsulated all-trans retinoic acid in the treatment of patients with advanced renal cell carcinoma. Cancer. 2002 Sep 15;95(6):1220-7. doi: 10.1002/cncr.10809.

Reference Type: BACKGROUND

PMID: 12216088 (View on PubMed)

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/?term=12216088

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

NYWCCC-0498-209

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1490

Identifier Type: -

Identifier Source: secondary_id

9804003327

Identifier Type: -

Identifier Source: org_study_id