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Comparison Study of Dendritic Cell Vaccine With and Without Cyclophosphamide to Treat Stage IV Melanoma Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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.

NCT00722098•Baylor Research Institute

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Biopsy-proven metastatic melanoma, Stages M1a, M1b, M1c
•2. HLA-A\*0201 phenotype
•3. Age: 21-75 years
•4. ECOG performance status 0-1
•5. Measurable metastatic melanoma lesions by physical examination or radiographs or scans.
•6. Adequate marrow function:
•* White count ≥ 4,000/microliter: Subjects who have recently completed chemotherapy will be allowed study entry with White count ≥ 3,500/microliter
•* Hemoglobin ≥ 10.0 gm: Subjects who have recently completed chemotherapy will be allowed study entry with Hemoglobin ≥ 9.0 gm.
•* Platelets ≥ 100,000/microliter
•7. Adequate hepatic function:
+10 more criteria

Exclusion Criteria

•1. Patients who have received \> 8 cycles of cytotoxic chemotherapy or metastatic melanoma
•2. Patients who have received any chemotherapy \< 4 weeks before the beginning of the trial
•3. Patients who have received interferon alpha (IFNα-2b) or sargramostim (GM-CSF) \< 4 weeks before the beginning of the trial
•4. Patients who have received high-dose interleukin-2 (IL-2) \< 4 weeks before the beginning of the trial
•5. Patients that have been diagnosed with more than 3 CNS melanoma lesions.
•6. Patients that have been diagnosed with more than 5 hepatic metastases or any hepatic metastasis \> 5 cm.
•7. Baseline serum LDH \> 1.1 times the upper limit of normal
•8. Patients who are HIV+ (HIV patients are often profoundly immunodeficient because of the viral infection and this additional parameter will interfere with the evaluation of DC induced immune responses in melanoma patients. Furthermore, the safety of collecting DCs, loading them with antigen and re-infusing these cells to HIV+ patients has not yet been determined.)
•9. Pregnancy (Pregnancy is associated with considerable immunosuppression 70 and this additional parameter will interfere with the evaluation of DC induced immune responses in melanoma patients. In addition, the safety and tolerability of cell body-loaded DC given subcutaneously is entirely unknown.)
•10. Patients who have received corticosteroids or other immunosuppressive agents \< 4 weeks before beginning the trial
+6 more criteria

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

April 1, 2011

Completion Date

July 1, 2012

Last Updated

July 8, 2013

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma Stage IV

Interventions

DC Vaccine & Cyclophosphamide

BIOLOGICAL

DC Vaccine & Placebo

BIOLOGICAL

Detection of Plasmatic Cell-free BRAF and NRAS Mutations : a New Tool for Monitoring Patients with Metastatic Malignant Melanoma Treated with Targeted Therapies or Immunotherapy ( MALT )

NCT03493230

Malignant Melanoma Stage IVMalignant Melanoma Stage III

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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