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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | April 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003665 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 IV Melanoma | ||||
| Official Title ICMJE | Phase I Trial of a Dendritic Cell Vaccine for Melanoma | ||||
| Brief Summary | RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. |
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| Detailed Description | OBJECTIVES: I. Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II dose, and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine. II. Determine the overall (complete and partial) response rate, duration of response, and optimal route of administration in this patient population. OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment arms. All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5 patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity. Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue. Treatment repeats every 2 weeks for a total of 4 doses. Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes. Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. Patients are followed at 2 weeks and then monthly for 3 months. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 14 months. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized | ||||
| Condition ICMJE | Melanoma (Skin) | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| 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 | 40 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Must be MHC Class I HLA-A2.1 PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: At least 2 months Hematopoietic: Platelet count at least 100,000/mm3 INR no greater than 1.5 mg/dL No coagulopathies including thrombocytopenia Hepatic: Partial thromboplastin time no greater than 50 seconds Renal: Not specified Cardiovascular: No major cardiac illness Pulmonary: No major respiratory illness Other: No active systemic infection or other illness No peripheral vascular disease Not pregnant or nursing Effective contraception required of all fertile patients during and for one month after completion of treatment PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior immunotherapy No concurrent immunotherapy Chemotherapy: At least 30 days since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 30 days since prior radiotherapy No concurrent radiotherapy Surgery: Not specified |
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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 | NCT00003665 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000066759, UPCC-4697, NCI-T98-0033 | ||||
| Study Sponsor ICMJE | University of Pennsylvania | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 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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