Dendritic Cells (DC) Vaccine for Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01042366
First received: January 4, 2010
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine what effect using an experimental tumor vaccine (a substance or group of substances meant to cause the immune system to respond to a tumor) made using patients' own tumor cells and blood cells will have on their melanoma.


Condition Intervention Phase
Metastatic Melanoma
Biological: Vaccination
Procedure: Leukapheresis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Metastatic Melanoma Using Autologous Mature Dendritic Cells

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo [ Time Frame: 12 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, and HLA-presented melanoma epitopes, using ELISPOT and MHC-peptide tetramer assays. [ Time Frame: 12 mo ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2002
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCs co-cultured with melanoma cells
DCs co-cultured with melanoma cells
Biological: Vaccination
Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Procedure: Leukapheresis
All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
Experimental: DCs pulsed with tumor cell lysates
DCs pulsed with tumor cell lysates
Biological: Vaccination
Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Procedure: Leukapheresis
All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.
Experimental: DCs fused with tumor cells
DCs fused with tumor cells
Biological: Vaccination
Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Procedure: Leukapheresis
All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have Stage III-IV melanoma (any tumor thickness and any number of lymph node involvement, and in-transit metastases, or distant metastases) (AJCC). Each diagnosis will be confirmed by pathology review at the Melanoma Center of the University of Pittsburgh Cancer Institute.
  • All subjects have to be HLA-A2 positive (required for immunologic testing).
  • Subjects must have recovered fully from surgery.
  • Availability of resectable or tissue banked tumor cells for autologous tumor dendritic cell vaccine preparation.
  • Sufficient number of tumor cells available for autologous tumor dendritic cell vaccine preparation (min 2.6 x 10 7).
  • Sufficient number of DCs of at least 12 X 10 6 for preparation of the autologous tumor dendritic cell vaccine preparation (if less than needed number of cells will be obtained by one course of leukopheresis, the second leukopheresis will be repeated 2 weeks apart).
  • Subjects must not have received any chemotherapy or immunotherapy within the four weeks preceding vaccination (six weeks for nitrosourea, mitomycin).
  • Subjects must have an expected survival of greater than or equal to 12 months.
  • Subjects must have an ECOG performance status 0 or 1.
  • Subjects must have the following initial and subsequent pretreatment
  • laboratory parameters: Granulocytes >=2,500/mm3 Lymphocytes >=1000/mm3 Platelets >100,000/mm3 Serum Creatinine <=1.5 X the ULN AST, ALT, GGT, LDH, Alk phos <= 2.5 X the ULN Serum Bilirubin <=1.5 X ULN
  • Subjects must be >= 18 years of age and must be able to understand the written informed consent.
  • No evidence of active infection, regardless of the degree of severity or localization. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment.
  • Subjects with measurable disease must have an evaluation for extent of disease (tumor staging) performed within 30 days of start of treatment.
  • Pretreatment baseline evaluations for laboratory parameters must be obtained within 10 to18 days of subject registration

Exclusion Criteria:

  • Subjects currently treated with anti inflammatory agents including glucocorticoid therapy are ineligible.
  • Subjects currently on treatment with steroids are ineligible, but may receive the DC autologous tumor dendritic cell vaccine 4 weeks after steroid cessation. Subjects on maintenance steroids because of adrenal insufficiency are eligible.
  • Subjects with severely abnormal liver function tests [AST (SGOT), ALT (SGPT), GGT, Alk.Phos, LDH, and total bilirubin greater than 2 X ULN].
  • Subjects with uncontrolled pain.
  • Subjects with autoimmune disease, HIV, and hepatitis
  • Subjects with symptomatic brain metastasis.
  • Subjects with active prior malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix).
  • Subjects who have been previously immunized with melanoma vaccine until 10 subjects have been registered in each treatment arm.
  • Subjects who are pregnant.
  • Subjects who have sensitivity to drugs to provide local anesthesia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042366

Locations
United States, Pennsylvania
Upmc Upci Hcc
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: John M Kirkwood, MD UPMC UPCI HCC
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01042366     History of Changes
Other Study ID Numbers: UPCI 01-171, 5P01CA073743
Study First Received: January 4, 2010
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 16, 2014