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Tracking Information | |||||
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First Received Date † | September 7, 2004 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | August 2004 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00091338 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma | ||||
Official Title † | A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Melanoma (Skin) | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | Rosenberg SA, Sportes C, Ahmadzadeh M, Fry TJ, Ngo LT, Schwarz SL, Stetler-Stevenson M, Morton KE, Mavroukakis SA, Morre M, Buffet R, Mackall CL, Gress RE. IL-7 administration to humans leads to expansion of CD8+ and CD4+ cells but a relative decrease of CD4+ T-regulatory cells. J Immunother. 2006 May-Jun;29(3):313-9. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00091338 | ||||
Responsible Party | |||||
Secondary IDs †† | NCI-04-C-0235 | ||||
Study Sponsor † | National Cancer Institute (NCI) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |