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Sponsored by: |
Baylor Research Institute |
Information provided by: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT00722098 |
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.
Condition | Intervention | Phase |
Stage IV Metastatic Melanoma |
Biological: Autologous dendritic cells generated from CD34+ hematopoietic progenitors and pulsed with melanoma and viral peptides Biological: Saline placebo |
Phase II |
MedlinePlus related topics: | Melanoma |
Drug Information available for: | Cyclophosphamide Sodium chloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Efficacy Study |
Official Title: | Melanoma Peptide-Loaded Dendritic Cell Vaccine in HLA-A*0201 Patients With Stage IV Melanoma: A Phase II Randomized Trial to Compare Vaccination With and Without Cyclophosphamide Treatment. |
Estimated Enrollment: | 96 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1. CPA: Experimental
Patients will be randomized in a 1:1 ratio to the two study arms. Randomization will be stratified by prior treatment with cytotoxic agents (Yes/No) and by stage of disease (M1a/M1b or M1c).
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Biological: Autologous dendritic cells generated from CD34+ hematopoietic progenitors and pulsed with melanoma and viral peptides
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. 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. |
2. Saline: Placebo Comparator
Patients will be randomized in a 1:1 ratio to the two study arms. Randomization will be stratified by prior treatment with cytotoxic agents (Yes/No) and by stage of disease (M1a/M1b or M1c).
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Biological: Saline placebo
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.
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Vaccination of patients with metastatic melanoma using ex vivo generated dendritic cells (DCs) loaded with tumor-associated antigen(s) have been shown to induce tumor-specific immunity against melanoma antigens measured by in vitro assays and, in some cases, tumor regression. At the present time, the numbers of recorded patients with metastatic melanoma who have been treated with DC vaccinations are too small to predict with certainty the future of overall therapeutic value of DC vaccinations in the management of patients with metastatic melanoma. The purpose of this study is to gather data on feasibility and efficacy of novel combination therapy of CPA and a DC vaccine outlined in this protocol to treat metastatic melanoma.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate marrow function:
Adequate hepatic function:
Adequate renal function:
No active CNS metastatic disease at screening.
Exclusion Criteria:
Contact: Judy Jahrig, RN | 214-820-1583 | judithja@baylorhealth.edu |
United States, Texas | |||||
Baylor University Medical Center | Recruiting | ||||
Dallas, Texas, United States, 75204 | |||||
Contact: Judy Jahrig, RN 214-820-1583 judithja@baylorhealth.edu | |||||
Contact: Doris Wood (214) 820-2610 DorisW@baylorhealth.edu | |||||
Principal Investigator: Joseph Fay, M.D. | |||||
Sub-Investigator: Jacques Banchereau, PhD | |||||
Sub-Investigator: Karolina Palucka, MD, PhD | |||||
Sub-Investigator: Luis Pineiro, MD |
Baylor Research Institute |
Principal Investigator: | Joseph Fay, M.D. | Baylor Institute for Immunology Research: Baylor University Medical Center |
Responsible Party: | Baylor Institute for Immunology Research ( : Dr. Joseph Fay, MD ) |
Study ID Numbers: | Baylor IRB #006-123 |
First Received: | July 23, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00722098 |
Health Authority: | United States: Food and Drug Administration |
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