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| Tracking Information | |||||
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| First Received Date ICMJE | September 6, 2002 | ||||
| Last Updated Date | July 23, 2009 | ||||
| Start Date ICMJE | April 2002 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00045383 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed | ||||
| Official Title ICMJE | A Randomized, Controlled Trial Of Melanoma Treatment: Comaprison Of Dendritic Cells Versus QS-21 As Adjuvants To Stimulate A-tumor Immunity | ||||
| Brief Summary | RATIONALE: Vaccines made from proteins may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is comparing two different vaccine therapies to see how well they work in treating patients with stage II or stage III melanoma that has been surgically removed. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
In both arms, patients then receive 3 booster injections of vaccine (that dose not contain KLH) SC monthly (weeks 4, 8, and 12) for a total of 4 injections. Patients are followed every 12 weeks. PROJECTED ACCRUAL: A total of 50 patients (25 per treatment arm) will be accrued for this study within 1.5-3 years. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, 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 | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
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 | NCT00045383 | ||||
| Responsible Party | Ralph Steinman, NYU Cancer Institute at New York University Medical Center | ||||
| Study ID Numbers ICMJE | CDR0000256890, NYU-RUH-NBH-0428-0401, RUH-NBH-0428-0401, NCI-5636 | ||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2009 | ||||
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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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