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| Tracking Information | |||||
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| First Received Date ICMJE | July 5, 2000 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | December 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005949 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma | ||||
| Official Title ICMJE | Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma | ||||
| Brief Summary | RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 3 additional courses after achieving CR. Patients are followed every 9 weeks for 3 years or until disease recurrence. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Melanoma (Skin) | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Roberts JD, Niedzwiecki D, Carson WE, Chapman PB, Gajewski TF, Ernstoff MS, Hodi FS, Shea C, Leong SP, Johnson J, Zhang D, Houghton A, Haluska FG; Cancer and Leukemia Group B. Phase 2 study of the g209-2M melanoma peptide vaccine and low-dose interleukin-2 in advanced melanoma: Cancer and Leukemia Group B 509901. J Immunother. 2006 Jan-Feb;29(1):95-101. | ||||
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* 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 ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
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 ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005949 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067886, CLB-509901 | ||||
| Study Sponsor ICMJE | Cancer and Leukemia Group B | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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