Kidney Cancer Clinical Trial
Official title:
Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
Verified date | March 2022 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York |
United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best Response as Measured by CT, Bone Scans, and Clinical Progression | After 8 weeks | ||
Primary | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | In 30 days after the last dose, an average of 1 year. | ||
Secondary | Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose | At baseline and 5th week | ||
Secondary | 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 | At 6 months and 12 months |
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