Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma

NCT00074230 | Completed Phase 1

• 3 other identifiers: ERLANGEN-DERMA-ER-DC-06CDR0000343699EU-20317
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous\* melanoma * Stage IV * 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 * Previously treated (e.g., excision of a single metastasis) CNS metastases are allowed provided there are no signs of active CNS metastases NOTE: \*Metastatic melanoma with unidentified primary tumor allowed provided an ocular melanoma can be definitely excluded and origin from the skin is likely PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 4 months Hematopoietic * WBC greater than 2,500/mm\^3 * Neutrophil count greater than 1,000/mm\^3 * Lymphocyte count greater than 700/mm\^3 * Platelet count greater than 75,000/mm\^3 * Hemoglobin greater than 9 g/dL * No bleeding disorder Hepatic * Bilirubin less than 2.0 mg/dL * No evidence of hepatitis B or C infection Renal * Creatinine less than 2.5 mg/dL Cardiovascular * No clinically significant heart disease Pulmonary * No respiratory disease 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) * Vitiligo allowed Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 4 weeks after study participation * Stable medical condition * No other major serious illness * No contraindication to leukapheresis * No organic brain syndrome or significant psychiatric abnormality that would preclude study participation or follow-up * No other active malignant neoplasm PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy * No other concurrent immunotherapy during and for 2 weeks after study participation Chemotherapy * More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas \[e.g., fotemustine\]) * No concurrent chemotherapy during and for 2 weeks after study participation Endocrine therapy * No concurrent corticosteroids during and for 2 weeks after study participation Radiotherapy * More than 2 weeks since prior radiotherapy * No prior radiotherapy to the spleen * Concurrent palliative radiotherapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed 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 * Selected accessible metastases may be removed for tumor infiltrating lymphocyte assay or other immunomonitoring investigations (e.g., expression of tumor antigens and HLA molecules) Other * No other concurrent investigational drug or paramedical substance during and for 2 weeks after study participation * No concurrent participation in another clinical trial * Concurrent palliative medication allowed (e.g., acetaminophen, indomethacin, or opiates)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen

Erlangen, D-91052, Germany

Location

MeSH Terms

Conditions

Melanoma

Interventions

MAGEA3 protein, human; MART-1 Antigen; Survivin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors; Inhibitor of Apoptosis Proteins; Apoptosis Regulatory Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Cell Cycle Proteins; Microtubule-Associated Proteins; Microtubule Proteins; Cytoskeletal Proteins

Study Officials

• Gerold Schuler

  Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: July 1, 2003
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

DE (1)