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