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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00109863 |
RATIONALE: Biological therapies, such as hu14.18-interleukin-2 fusion protein, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating patients with advanced melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: hu14.18-IL2 fusion protein |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma |
Estimated Enrollment: | 30 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive hu14.18-interleukin-2 fusion protein IV over 4 hours on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of symptomatic disease progression or unacceptable toxicity. Patients then undergo disease reassessment. Patients with an objective partial or complete clinical response or stable disease receive 2 additional courses of treatment.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
No known standard curative therapy exists
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No immediate requirement for palliative radiotherapy
Surgery
Other
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Mark R. Albertini, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000426431, WCCC-CO-04601, NCI-6304, WCCC-H-2004-0396 |
Study First Received: | May 3, 2005 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00109863 |
Health Authority: | United States: Federal Government |
recurrent melanoma stage IV melanoma |
Recurrence Melanoma Neuroendocrine Tumors Antibodies, Monoclonal Neuroectodermal Tumors Antibodies Interleukin-2 |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Denileukin diftitox Neuroepithelioma Nevus Immunoglobulins |
Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Pharmacologic Actions Neoplasms |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Nevi and Melanomas Analgesics Peripheral Nervous System Agents Central Nervous System Agents |