Vaccine Therapy in Treating Patients With Stage IV Melanoma
Recruitment status was: Active, not recruiting
|First Submitted Date ICMJE||August 3, 2005|
|First Posted Date ICMJE||August 4, 2005|
|Last Update Posted Date||September 17, 2013|
|Start Date ICMJE||April 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00126685 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Vaccine Therapy in Treating Patients With Stage IV Melanoma|
|Official Title ICMJE||Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With Unselected Autologous Amplified Tumor-RNA|
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IV melanoma.
OUTLINE: This is an open-label, nonrandomized study. Patients are sequentially assigned to receive dendritic cells (DC) transfected at either immature or mature stage.
Approximately 2-3 weeks before leukapheresis, patients undergo surgical excision or biopsy of the tumor to obtain tumor tissue for RNA isolation. RNA is amplified from the tumor sample by polymerase chain reaction (PCR). Patients then undergo leukapheresis to harvest peripheral blood mononuclear cells for the production of DC on day -14 . DC at immature or mature stage are transfected with autologous PCR-amplified tumor RNA to produce the vaccine. Patients receive vaccine intradermally (ID) on days 1, 15, 29, 43, 57, and between days 71-74 in the absence of disease progression or unacceptable toxicity. Patients undergo evaluation between days 71-74. Patients with responding or stable disease or minor disease progression receive booster vaccine ID on days 99, 127, between days 162-164, on day 205, between days 253-255, 351-354, 442-444, 533-535, 624-626, and 715-718 in the absence of disease progression or unacceptable toxicity. Patients also undergo additional leukapheresis between days 71-74, 351-354, and 715-718. Patients with responding or stable disease may continue to undergo leukapheresis and receive booster vaccine ID every 12-24 weeks off study.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Melanoma (Skin)|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||30|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
NOTE: **Major surgery not allowed for the acquisition of metastatic material solely for RNA isolation
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Germany|
|Removed Location Countries|
|NCT Number ICMJE||NCT00126685|
|Other Study ID Numbers ICMJE||CDR0000435933
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||June 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP