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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004141 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one drug with different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: aldesleukin Biological: recombinant interferon alfa Biological: sargramostim Drug: cisplatin Drug: dacarbazine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma |
Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes sequentially on day 1, followed by sargramostim (GM-CSF) subcutaneously (SC) on days 2-7, interleukin-2 SC on days 8-14, and interferon alfa SC on days 8, 10, 12, and 14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression, and then every 8-12 weeks thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within 3 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No second malignancy within the past 5 years, except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 |
Study Chair: | Thomas F. Gajewski, MD, PhD | University of Chicago |
Study ID Numbers: | CDR0000067372, UCCRC-9372, UCCRC-CTRC-9821, NCI-G99-1615 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004141 History of Changes |
Health Authority: | United States: Federal Government |
stage III melanoma stage IV melanoma recurrent melanoma |
Interferon-alpha Interferon Type I, Recombinant Anti-HIV Agents Dacarbazine Immunologic Factors Interferons Angiogenesis Inhibitors Antiviral Agents Recurrence Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Aldesleukin Anti-Retroviral Agents Cisplatin Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Antineoplastic Agents, Alkylating Nevus Interferon Alfa-2a Alkylating Agents |
Anti-Infective Agents Interferon Type I, Recombinant Dacarbazine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Angiogenesis Modulating Agents Growth Inhibitors |
Alkylating Agents Interferon-alpha Anti-HIV Agents Neoplasms by Histologic Type Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Antineoplastic Agents, Alkylating Interferon Alfa-2a |