Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma

NCT00683670 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 07-0652 / 826850
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• Immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.

  * Starting on Day 0, two tubes will be drawn weekly until Day 64. Thereafter, two tubes will be drawn every 21 days until Day 190. For patients receiving maintenance treatment, blood is drawn every month. * Data are presented as the percentage of CD8+ T cells positive for tetramer binding based on gating variables set using the iMASC reagent kit (Beckman Coulter).

  Through completion of treatment

• Safety and tolerability of the mature dendritic cell vaccine as measured by adverse events

  The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.

  30 days after end of treatment

Secondary Outcomes (4)

• Time to progression

  Through completion of treatment or until progressive disease

• Regulatory T cell depletion after cyclophosphamide administration.

  Day -3 (72 hours prior to vaccine dose 1)

• Safety and side effect profile of mDC administered to patients given after a single dose of cyclophosphamide.

  Day 0 (prior to vaccine dose 1)

• Clinical response rate using RECIST criteria

  After third vaccine, sixth vaccine, and then every 8 weeks

Study Arms (3)

Dendritic Cell Vaccine (First Group)

EXPERIMENTAL

Blood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.

Drug: cyclophosphamide; Biological: Mature dendritic cell vaccine

Dendritic Cell Vaccine (Second Group)

EXPERIMENTAL

Blood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.

Drug: cyclophosphamide; Biological: Mature dendritic cell vaccine

Dendritic Cell Vaccine (Third Group)

EXPERIMENTAL

Blood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 6 weeks for a total of 3 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 in order to collect PBMC for immune monitoring.

Drug: cyclophosphamide; Biological: Mature dendritic cell vaccine

Interventions

cyclophosphamide DRUG

Also known as: Cytoxan

Dendritic Cell Vaccine (First Group); Dendritic Cell Vaccine (Second Group); Dendritic Cell Vaccine (Third Group)

Mature dendritic cell vaccine BIOLOGICAL

Dendritic Cell Vaccine (First Group); Dendritic Cell Vaccine (Second Group); Dendritic Cell Vaccine (Third Group)

Eligibility Criteria

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

You may qualify if:

• Unresectable stage III and stage IV M1a/M1b/M1c melanoma including patients with uveal melanoma
• Age ≥ 18 years
• Life expectancy ≥ 4 months
• ECOG performance status 0-2
• At least 28 days from prior treatment (including adjuvant interferon) except in cases of a BRAF inhibitor (such as vemurafenib); concurrent treatment with a BRAF inhibitor +/- MEK inhibitor is permitted
• Required initial laboratory values (submitted within 14 days prior to registration):
• WBC \>3,000/mm3
• Hg ≥ 9.0 gm/dl
• Platelets \>75,000/mm3
• Serum Bilirubin \< 2.0 mg/dl
• Serum Creatinine \< 2.0 mg/dl
• Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.

You may not qualify if:

• Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilumumab, anti-PD1, and BRAF inhibitor) is permitted.
• Active untreated CNS metastasis
• Active infection
• Prior malignancy (except non-melanoma skin cancer) within 3 years
• Pregnant or nursing
• Concurrent treatment with corticosteroids; local (inhaled or topical) steroids are permitted.
• Inability to provide adequate informed consent
• Known allergy to eggs
• Prior history or uveitis or autoimmune inflammatory eye disease.
• Known positivity for hepatitis BsAg, hepatitis C antibody, or HIV antibody.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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  BACKGROUND

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Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Melanoma

Interventions

Cyclophosphamide

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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Gerald P. Linette, M.D., Ph.D.

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 23, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)