Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Melanoma (Skin)
- Sponsor
- Lisata Therapeutics, Inc.
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV or recurrent melanoma.
Detailed Description
OBJECTIVES: * Determine the safety of immunization with autologous in vitro-treated tumor cells and dendritic cells in combination with sargramostim (GM-CSF) in patients with stage IV or recurrent melanoma. * Determine the frequency of conversion of delayed tumor hypersensitivity tests in patients treated with this regimen. * Determine the progression-free and overall survival in patients treated with this regimen. * Determine the objective tumor response rate in patients with measurable melanoma treated with this regimen. OUTLINE: Patients are stratified according to presence of measurable disease at study initiation (yes vs no). Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic disease after harvest may receive systemic therapy (biologic therapy and/or chemotherapy) during tumor cell line expansion over approximately 4 months. The tumor cell line is expanded, irradiated, and treated with interferon gamma. Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC) to obtain dendritic cells (DC). The PBMC are treated with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce DC. The DC are then cultured with the treated tumor cells for 18 hours. Patients undergo delayed tumor hypersensitivity tests intradermally 1 week prior to vaccination and again at week 4. Patients receive vaccine therapy comprising autologous treated tumor cells and dendritic cells suspended in GM-CSF subcutaneously weekly for 3 weeks. Vaccine therapy continues monthly for an additional 5 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 3 months for 4 years. PROJECTED ACCRUAL: A total of 30-80 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
Time Frame: treatment
To determine the frequency of conversion of delayed tumor hypersensitivity (DTH) tests with irradiated autologous tumor cells, in patients who received an autologous dendritic cell/tumor cell vaccine with GMCSF
Time Frame: treatment
Secondary Outcomes
- To determine the objective tumor response rate in patients with metastatic melanoma who still had measurable disease at the time vaccine treatment was given(follow-up)