Clinical trial NCT00101166: Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
stage III melanoma
stage IV melanoma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Society of Clinical Oncology
name: Society of Surgical Oncology (SSO)
First posted: 2005-01-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.

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) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Partial Response
timeFrame: Average of 14 months
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment
timeFrame: Average of 14 months
measure: Number of Participants With Stable Disease
timeFrame: Average of 14 months
measure: Time to Progression (TTP) in Months
timeFrame: Average of 14 months
measure: Overall Survival (OS) in Months
timeFrame: Average of 14 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Sophie Dessureault, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: