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Sponsored by: |
Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074230 |
RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: MART-1 antigen Biological: keyhole limpet hemocyanin Biological: recombinant MAGE-3.1 antigen Biological: survivin antigen Biological: therapeutic autologous dendritic cells |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With RNAs Encoding for Mage-3, MelanA, and Survivin Antigens |
Study Start Date: | July 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized study.
Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous* melanoma
No active CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
No active autoimmune disease (e.g., lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, or inflammatory bowel disease)
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Concurrent surgical therapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed
Other
Germany | |
Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen | Recruiting |
Erlangen, Germany, D-91052 | |
Contact: Gerold Schuler 49-9131-85-33164 |
Principal Investigator: | Gerold Schuler | Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen |
Study ID Numbers: | CDR0000343699, ERLANGEN-DERMA-ER-DC-06, EU-20317 |
Study First Received: | December 10, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00074230 History of Changes |
Health Authority: | Unspecified |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Immunologic Factors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Adjuvants, Immunologic Neuroepithelioma |
Nevus Keyhole-limpet hemocyanin Melanoma, Familial Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Immunologic Factors Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Keyhole-limpet hemocyanin Pharmacologic Actions |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas |