Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: recombinant interferon alfa Drug: tretinoin liposome |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma |
- Response as measured by CT, bone scans, and clinical progression at 8 weeks after first dose [ Designated as safety issue: No ]
- Toxicity by clinical evaluation from first dose to 30 days after last dose [ Designated as safety issue: Yes ]
- Retinoic acid receptor expression on tissue as measured by the presence of peripheral blood lymphocytes during the first and fifth dose [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
| Estimated Enrollment: | 43 |
| Study Start Date: | January 1999 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Study Chair: | David M. Nanus, MD | Weill Medical College of Cornell University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003656 History of Changes |
| Other Study ID Numbers: | CDR0000066748, NYWCCC-0498-209, NCI-V98-1490 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Tretinoin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Keratolytic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013