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Status:

COMPLETED

Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma

Lead Sponsor:

University Hospital Erlangen

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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 t...

Detailed Description

OBJECTIVES: Primary * Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells (DC) transfected with RNAs encoding Melan-A, MAGE-3, and survivin antigens...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    July 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2014

    Estimated Enrollment :

    82 Patients enrolled

    Trial Details

    Trial ID

    NCT00074230

    Start Date

    July 1 2003

    End Date

    March 1 2014

    Last Update

    May 12 2015

    Active Locations (1)

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    Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen

    Erlangen, Germany, D-91052