Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
recombinant interferon alfa
+ tretinoin liposome
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: January 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
New York Weill Cornell Cancer Center at Cornell University
New York, United StatesOpen New York Weill Cornell Cancer Center at Cornell University in Google MapsHerbert Irving Comprehensive Cancer Center at Columbia University
New York, United States