Dendritic Cells (DC) Vaccine for Metastatic Melanoma

NCT01042366 | Terminated Phase 2 Results DMC

• 2 other identifiers: UPCI 01-1715P01CA073743
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Melanoma

Keywords

Melanoma

Outcome Measures

Primary Outcomes (2)

• Delayed Type Hypersensitivity (DTH) Response

  Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo

  12 mo

• ELISpot Response to Melanoma

  Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, and HLA-presented melanoma epitopes, using ELISPOT and MHC-peptide tetramer assays.

  12 mo

Study Arms (3)

Vaccine co-cultured with melanoma cells

EXPERIMENTAL

Dendritic Cells co-cultured with melanoma cells injected as a vaccine intra/peri-nodally under ultrasound guidance

Biological: Vaccination

Vaccine pulsed with tumor cell lysates

EXPERIMENTAL

Dendritic Cells pulsed with tumor cell lysates were injected as a vaccine intra/peri-nodally under ultrasound guidance

Biological: Vaccination

Vaccine fused with tumor cells

EXPERIMENTAL

Dendritic Cells fused with tumor cells were injected as a vaccine intra/peri-nodally under ultrasound guidance

Biological: Vaccination

Interventions

Vaccination BIOLOGICAL

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.

Vaccine co-cultured with melanoma cells; Vaccine fused with tumor cells; Vaccine pulsed with tumor cell lysates

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• John Kirkwood: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Upmc Upci Hcc

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Vaccination

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)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Results Point of Contact

• Title: John Kirkwood, MD
• Organization: University of Pittsburgh

KirkwoodJM@upmc.edu

(412) 623-7707

Study Officials

• John M Kirkwood, MD

  UPMC UPCI HCC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: October 1, 2002
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 16, 2017
• Results First Posted: August 16, 2017

Record last verified: 2017-07

Locations

US (1)