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Sponsors and Collaborators: |
The Cleveland Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004244 |
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.
Interferon alfa may interfere with the growth of cancer cells. Combining interleukin-12 and interferon alfa may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 and interferon alfa in treating patients with metastatic kidney cancer or malignant melanoma.
Condition | Intervention | Phase |
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Kidney Cancer Melanoma (Skin) |
Biological: recombinant interferon alfa Biological: recombinant interleukin-12 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase I Trial of rhIL-12 and rHuIFN-a2b in Patients With Metastatic Renal Cell Carcinoma or Malignant Melanoma |
Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study, followed by a randomized study.
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Once the MTD is established, additional patients are accrued and randomized to 1 of the following treatment arms:
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for the dose escalation portion of this study. An additional 18 patients (5 in arm I, 5 in arm II, and 8 in arm III) will be accrued to the randomized portion of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Study Chair: | Ronald M. Bukowski, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000067489, CCF-IRB-3063, NCI-T99-0028 |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004244 History of Changes |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer stage IV melanoma recurrent melanoma |
Urinary Tract Neoplasm Interferon Type I, Recombinant Interleukin-12 Immunologic Factors Urogenital Neoplasms Urologic Neoplasms Melanoma Renal Cancer Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Kidney Diseases Interferon-alpha |
Kidney Cancer Interferons Adjuvants, Immunologic Angiogenesis Inhibitors Antiviral Agents Recurrence Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors Carcinoma, Renal Cell Nevus Adenocarcinoma Interferon Alfa-2a Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Interferon Type I, Recombinant Interleukin-12 Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Melanoma Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal |
Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Interferon-alpha Neoplasms by Histologic Type Growth Substances Interferons Adjuvants, Immunologic Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors |