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Combined Modality Treatment for Patients With Stage IV Melanoma

NCT00313235 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-06-13

No results posted yet for this study

Summary

The purpose of this study is to test a combined treatment using cyclophosphamide and a novel dendritic cell vaccine in patients with Stage IV melanoma.

Conditions

  • Malignant Melanoma Stage IV

Interventions

BIOLOGICAL

DC Vaccine and Cyclophosphamide

Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10\^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site). Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks. CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure.

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Joseph W. Fay, MD · Baylor Health Care System

  • Anna Karolina Palucka, MD, PhD · Baylor Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2011-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00313235 on ClinicalTrials.gov