Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma
NCT ID: NCT00683670
Last Updated: 2025-06-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
17 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-08-31
Study Completion Date
2016-06-30
Brief Summary
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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.
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Detailed Description
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Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will be given cyclophosphamide 300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells. All patients will receive mature DC for each dose of vaccine. For each dose all patients will receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (G209-2M and G280-9V) plus up to an additional 10 unique melanoma tumor-specific peptides. All patients will receive booster doses with mature DC. The DC vaccine will be given intravenously every three weeks for a total of six vaccine doses. Peripheral blood (16 ml) will be taken weekly to monitor the immune response to each peptide by tetramer assay. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Restaging is performed after three and six vaccine doses. Patients with stable disease or better (partial response/complete response) after six doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
Conditions
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Melanoma
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Dendritic Cell Vaccine (First Group)
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.
Group Type
EXPERIMENTAL
cyclophosphamide
Intervention Type
DRUG
Mature dendritic cell vaccine
Intervention Type
BIOLOGICAL
Dendritic Cell Vaccine (Second Group)
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.
Group Type
EXPERIMENTAL
cyclophosphamide
Intervention Type
DRUG
Mature dendritic cell vaccine
Intervention Type
BIOLOGICAL
Dendritic Cell Vaccine (Third Group)
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.
Group Type
EXPERIMENTAL
cyclophosphamide
Intervention Type
DRUG
Mature dendritic cell vaccine
Intervention Type
BIOLOGICAL
Interventions
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cyclophosphamide
Intervention Type
DRUG
Mature dendritic cell vaccine
Intervention Type
BIOLOGICAL
Other Intervention Names
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Cytoxan
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Pennsylvania
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Gerald P. Linette, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Countries
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United States
References
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DERIVED
Carreno BM, Becker-Hapak M, Huang A, Chan M, Alyasiry A, Lie WR, Aft RL, Cornelius LA, Trinkaus KM, Linette GP. IL-12p70-producing patient DC vaccine elicits Tc1-polarized immunity. J Clin Invest. 2013 Aug;123(8):3383-94. doi: 10.1172/JCI68395. Epub 2013 Jul 11.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://www.siteman.wustl.edu
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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07-0652 / 826850
Identifier Type: -
Identifier Source: org_study_id
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Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT03735589
WITHDRAWN
PHASE1/PHASE2
A Pilot Study of Tumor Cell Vaccine for High-risk Solid Tumor Patients Following Stem Cell Transplantation
NCT00405327
COMPLETED
PHASE2
Dendritic Cell Vaccine for Head and Neck Cancer
NCT00492947
WITHDRAWN
PHASE1
Dendritic Cell Vaccination for Patients with Solid Tumors
NCT01291420
COMPLETED
PHASE1/PHASE2
External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma
NCT00365872
COMPLETED
PHASE2
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
NCT05325632
RECRUITING
PHASE2
Dendritic Cell Vaccine for Children and Adults With Sarcoma
NCT01803152
COMPLETED
PHASE1
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
NCT00010127
TERMINATED
PHASE1