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Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Cancer

Intervention: recombinant interferon alfa (Biological); tretinoin liposome (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
David M. Nanus, MD, Study Chair, Affiliation: Weill Medical College of Cornell University


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.

Clinical Details

Official title: Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Secondary outcome:

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

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- Histologically confirmed metastatic renal cell carcinoma

- Bidimensionally measurable disease

- No active brain metastases


- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 3 months


- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- No coagulation disorders


- 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


- Creatinine less than 2 mg/dL OR

- Creatinine clearance greater than 50 mL/min

- No clinically significant renal disease


- No clinically significant cardiac disease

- No thrombophlebitis


- No severe debilitating pulmonary disease

- No pulmonary embolism


- 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


- No more than 1 prior chemotherapy regimen

Endocrine therapy:

- No concurrent steroids


- At least 4 weeks since prior radiotherapy


- At least 4 weeks since prior major surgery


- No prior retinoid therapy

Locations and Contacts

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York 10032, United States

New York Weill Cornell Cancer Center at Cornell University, New York, New York 10021, United States

Additional Information

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

Related publications:

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.

Starting date: January 1999
Last updated: February 6, 2009

Page last updated: August 23, 2015

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