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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000343699 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20317 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized study.
Patients receive antigen-pulsed (with or without KLH) DC vaccination subcutaneously (SC) on days 1, 15, 43, and 71 in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may proceed to the phase II portion of the 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Dendritic Cells loaded with MAGE-A3, MelanA and Survivin | Biological | Within cohort 1 patients received the vaccine intradermally; in cohort 2 the route of Administration was intravenous Infusion, half of the patients had additional loading with RNA coding for EL-Selektin; in cohort 3 the vaccines was again infused intravenously, the cells were matured not with MCM.mimic as in cohort 1 and 2 but either with TriMix or MCM-mimic plus CD40L-RNA. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability at every visit | 3 months | |
| Overall survival as assessed by clinical staging (CT scan, positron emission tomography [PET]) every 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression as assessed by clinical staging (CT scan, PET) every 3 months | 3 months | |
| Objective tumor response as assessed by clinical staging (CT scan, PET) every 3 months | 3 months | |
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DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous* melanoma
Incurable by surgical resection
Progressive disease after at least 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy)
Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or noninvasive radiological procedures
No active CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
HIV-1 and HIV-2 negative
HTLV-1 negative
No active systemic infection
No immunodeficiency disease
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
Recovered from prior surgery
No prior splenectomy
No prior organ allografts
Concurrent surgical therapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed
Other
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| Name | Affiliation | Role |
|---|---|---|
| Gerold Schuler | Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen | Erlangen | D-91052 | Germany |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C072013 | MAGEA3 protein, human |
| D058965 | MART-1 Antigen |
| D000077022 | Survivin |
| ID | Term |
|---|---|
| D058950 | Melanoma-Specific Antigens |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Duration of response as assessed by clinical staging (CT scan, PET) every 3 months |
| 3 months |
| Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit | 3 months |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D051034 | Inhibitor of Apoptosis Proteins |
| D051017 | Apoptosis Regulatory Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D018797 | Cell Cycle Proteins |
| D008869 | Microtubule-Associated Proteins |
| D008868 | Microtubule Proteins |
| D003598 | Cytoskeletal Proteins |