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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Biological: Bystander-Based Autologous Tumor Cell Vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00101166

0407-657 (Other Identifier)

MCC-13639

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Vaccine Therapy

Experimental group

Description:

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.

Treatment:

Biological: Bystander-Based Autologous Tumor Cell Vaccine