Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
18 Years
N/A
Both
Kidney Cancer
Trial Information
Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response as measured by CT, bone scans, and clinical progression at 8 weeks after first dose
Safety Issue:
No
Principal Investigator
David M. Nanus, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
United States: Federal Government
Study ID:
CDR0000066748
NCT ID:
NCT00003656
Start Date:
January 1999
Completion Date:
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
| New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
