Status:
COMPLETED
Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma
Lead Sponsor:
University of Pennsylvania
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00683670
Start Date
August 1 2008
End Date
June 1 2016
Last Update
June 29 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110