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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091338 |
RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: recombinant interleukin-7 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma |
Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of interleukin-7 (IL-7).
Patients receive IL-7 subcutaneously (SC) on days 0, 3, 6, 9, 12, 15, 18, and 21. Patients also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 SC on days 0, 7, 14, and 21 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of IL-7 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 toxicity. After the MTD is determined, an additional 13 patients are treated at that dose level.
Patients are followed at 1, 2, and 5 weeks, at 3 and 6 months, and then at 1 year.
PROJECTED ACCRUAL: A total of 3-37 patients will be accrued for this study within 1-12.3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Hepatitis B negative
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent chronic anticoagulation therapy (e.g., high-dose warfarin, heparin, or aspirin)
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000387802, NCI-04-C-0235 |
Study First Received: | September 7, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00091338 History of Changes |
Health Authority: | United States: Federal Government |
recurrent melanoma stage IV melanoma |
Neuroectodermal Tumors Immunologic Factors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Adjuvants, Immunologic Neuroepithelioma |
Freund's Adjuvant Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Immunologic Factors Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Freund's Adjuvant |