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

NCT ID: NCT00101166

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2010-03-31

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaccine Therapy

Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.

Group Type: EXPERIMENTAL

Bystander-Based Autologous Tumor Cell Vaccine

Intervention Type: BIOLOGICAL

The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.

Interventions

Bystander-Based Autologous Tumor Cell Vaccine

The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

GM.CD40L; bystander cells; Melanoma Vaccine; Immunotherapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

American Society of Clinical Oncology

OTHER

Sponsor Role: collaborator

Society of Surgical Oncology (SSO)

UNKNOWN

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Dessureault, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

0407-657

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-13639

Identifier Type: -

Identifier Source: org_study_id