Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma

Completed · Phase 2

Conditions studied: Melanoma (Skin)

In brief

The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.

Key facts

Study ID

NCT00101166

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

43

Starts

2004-10-01

Expected to finish

2010-03-01

Last updated by the study team

2018-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed stage IIIC or stage IV melanoma
• Measurable disease
• Age 18 or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• No radiation therapy within 2 weeks prior to first vaccine administration
• No chemotherapy within 4 weeks prior to first vaccine administration
• No steroid therapy within 4 weeks prior to first vaccine administration
• No surgery within 10 days prior to first vaccine administration
• Patient's written informed consent
• Patient's ability to comply with the visit schedule and assessments required by the protocol
• Adequate organ function (measured within a week of beginning treatment):
• White blood count (WBC) > 3,000/mm\^3 and absolute neutrophil count (ANC) >1500/mm\^3
• Platelets > 100,000/mm\^3
• Hematocrit > 25% and Hgb > 8 g/dL
• Bilirubin < 2.0 mg/dL
• Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min

You may not qualify if…

• Symptomatic or untreated brain metastasis
• Any serious ongoing infection
• Current corticosteroid or other immunosuppressive therapy
• Any other pre-existing immunodeficiency condition (including known HIV infection)
• Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment)
• ECOG performance status of 2, 3, or 4
• Any second active primary cancer

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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