A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma
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) experimental "bystander" cells. All the cells in the vaccine
will be treated with high-dose X-rays to make sure that none of them grow and cause more
cancer. The bystander cells, called "GM.CD40L", are human cells that have been genetically
changed. The original cells, called K562, had the genes for human GM-CSF and CD40L inserted
into them. These changes are designed to help boost the patient's immune system to better
fight the cancer in their body.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Partial Response
Outcome Description:
Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome Time Frame:
Average of 14 months
Safety Issue:
No
Principal Investigator
Sophie Dessureault, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
MCC-13639
NCT ID:
NCT00101166
Start Date:
October 2004
Completion Date:
March 2010
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage III melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
