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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Malignant Melanoma Stage IV

In brief

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.

Key facts

Study ID

NCT00722098

Run by

Baylor Research Institute

People needed

9

Starts

2008-06-01

Expected to finish

2012-07-01

Last updated by the study team

2013-07-08

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy-proven metastatic melanoma, Stages M1a, M1b, M1c
• HLA-A*0201 phenotype
• Age: 21-75 years
• ECOG performance status 0-1
• Measurable metastatic melanoma lesions by physical examination or radiographs or scans.
• 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
• Adequate hepatic function:
• Bilirubin ≤ 1.5/mg/dL
• Alkaline phosphatase ≤ 5 times the upper limit of normal
• SGOT ≤ 5 times the upper limit of normal
• SGPT ≤ 5 times the upper limit of normal
• Adequate renal function:
• Serum creatinine ≤ 1.5/mg/dL
• No active CNS metastatic disease at screening.
• Patients with a history of CNS melanoma lesions must have had lesions resected by surgery and/or gamma knife irradiation at least 3 months prior to study entry.
• The total number of CNS lesions at diagnosis should not have exceeded 3.
• Written informed consent

You may not qualify if…

• Patients who have received > 8 cycles of cytotoxic chemotherapy or metastatic melanoma
• Patients who have received any chemotherapy < 4 weeks before the beginning of the trial
• Patients who have received interferon alpha (IFNα-2b) or sargramostim (GM-CSF) < 4 weeks before the beginning of the trial
• Patients who have received high-dose interleukin-2 (IL-2) < 4 weeks before the beginning of the trial
• Patients that have been diagnosed with more than 3 CNS melanoma lesions.
• Patients that have been diagnosed with more than 5 hepatic metastases or any hepatic metastasis > 5 cm.
• Baseline serum LDH > 1.1 times the upper limit of normal
• 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.)
• 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.)
• Patients who have received corticosteroids or other immunosuppressive agents < 4 weeks before beginning the trial
• Patients with active asthma and/or on treatment for asthma
• Patients with angina pectoris
• Patients with congestive heart failure
• Patients with a history of autoimmune disease including lupus erythematosus, rheumatoid arthritis or thyroiditis
• Patients with active infections including viral hepatitis
• Patients with a history of neoplastic disease other than melanoma < 5 years prior to entry on the trial except for patients with carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin. Patients who have any of these two types of cancer and melanoma can be included.

Where it is running

• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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