Status:
COMPLETED
Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
American Society of Clinical Oncology
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
The vaccine will be made by mixing two kinds of cells: 1) some of the patient's own malignant melanoma cells which were removed by surgery and then processed in the Cell Therapy Laboratory, and 2) exp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00101166
Start Date
October 1 2004
End Date
March 1 2010
Last Update
February 28 2018
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497