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| Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00100906 |
Purpose
RATIONALE: Tretinoin may help cells that are involved in the body's immune response to work better. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving tretinoin together with interleukin-2 may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving three different doses of tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: aldesleukin Drug: tretinoin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer |
| Estimated Enrollment: | 36 |
| Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label study. Specimens are stratified according to patient prognostic factors, tumor bulk, and extent of dendritic cell to circulating immature cell ratio derangement. Patients are randomized to 1 of 3 tretinoin doses.
Patients receive oral tretinoin three times daily on days 1-7 of week 1. Patients then receive interleukin-2 subcutaneously on days 1-5 of weeks 3-8.
Treatment repeats every 10-11 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 27-36 patients (9-12 per treatment arm) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell cancer
Underwent complete or partial nephrectomy more than 90 days ago
No more than 2 of the following adverse factors:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following cardiovascular conditions within the past year:
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
More than 7 days since prior external-beam radiotherapy
Surgery
Other
Prior adjuvant therapy allowed
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| Study Chair: | Mayer Fishman, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Study ID Numbers: | CDR0000407544, MCC-13920, MCC-IRB-102626 |
| Study First Received: | January 6, 2005 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00100906 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer recurrent renal cell cancer clear cell renal cell carcinoma |
|
Urinary Tract Neoplasm Kidney Cancer Anti-HIV Agents Urogenital Neoplasms Urologic Neoplasms Antiviral Agents Recurrence Carcinoma Keratolytic Agents Aldesleukin Renal Cancer |
Anti-Retroviral Agents Urologic Diseases Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Clear Cell Renal Cell Carcinoma Tretinoin Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Antineoplastic Agents Urogenital Neoplasms Urologic Neoplasms Antiviral Agents Pharmacologic Actions Carcinoma Keratolytic Agents Neoplasms Neoplasms by Site |
Aldesleukin Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Tretinoin Kidney Diseases Adenocarcinoma Dermatologic Agents Neoplasms, Glandular and Epithelial |