MedTrace Logo

Comparison Study of Dendritic Cell Vaccine With and Without Cyclophosphamide to Treat Stage IV Melanoma Patients

NCT00722098 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-07-08

No results posted yet for this study

Summary

The purpose of this study is to determine whether the combination of chemotherapy (Cyclophosphamide) and CD34-DC vaccines results in the improved rate of clinical responses for stage IV melanoma patients.

Conditions

  • Malignant Melanoma Stage IV

Interventions

BIOLOGICAL

DC Vaccine & Cyclophosphamide

Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive either CPA 300mg/m2 for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7.

BIOLOGICAL

DC Vaccine & Placebo

Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive saline for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7.

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Joseph Fay, M.D. · Baylor Institute for Immunology Research: Baylor University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-04-30
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00722098 on ClinicalTrials.gov