Dendritic Cells (DC) Vaccine for Metastatic Melanoma

Metastatic Melanoma Clinical Trial

Official title:

Randomized Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Metastatic Melanoma Using Autologous Mature Dendritic Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042366
• Other study ID #: UPCI 01-171
• Secondary ID: 5P01CA073743
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2010
• Last updated: May 5, 2014
• Start date: October 2002
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

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.

Locations

Country	Name	City	State
United States	Upmc Upci Hcc	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo		12 mo	No
Secondary	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	No