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| Tracking Information | |||||
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| First Received Date ICMJE | June 5, 2003 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | May 2003 | ||||
| Estimated Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00062218 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Response rate [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Therapy In Treating Patients At High Risk For Recurrence Of Melanoma | ||||
| Official Title ICMJE | Randomized Comparison Of Peptide Immunization In Patients At High Risk For Recurrence Of Melanoma | ||||
| Brief Summary | RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying how well vaccine therapy works in treating patients at high risk for recurrence of melanoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment repeats every 12 weeks for 4 courses in the absence of unacceptable toxicity or progressive disease. Patients with tumor recurrence during the first course with an easily resectable lesion undergo surgery to eradicate evidence of disease and continue with immunization. Patients with disease progression, other than the preceding, do not receive further peptide administration and are considered for interleukin-2 (IL-2) therapy.
Patients are followed every 3 months for 1 year and then every 6 months for 5 years or until disease progression. PROJECTED ACCRUAL: A total of 76-132 patients (19-33 per treatment arm) will be accrued for this study within 2 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Active Control | ||||
| Condition ICMJE | Melanoma (Skin) | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 132 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 16 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 | NCT00062218 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000304577, NCI-03-C-0172, NCI-6211 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2007 | ||||
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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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