Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania; University of Pennsylvania
• Treatments: Cyclophosphamide; Vaccines

Criteria

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.

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.