Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HOAG-VACCINE-MEL | |||
| NCI-V01-1646 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological/Vaccine | Experimental | Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic autologous dendritic cells | Biological | Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV or recurrent melanoma
Planned resection of tumor
No active CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert O. Dillman, MD, FACP | Hoag Memorial Hospital Presbyterian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Cancer Center at Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Dillman RO, Schiltz PM, Selvan R, et al.: Patient-specific cancer vaccine of cultured autologous tumor cells and autologous dendritic cells. [Abstract] J Immunother 24 (5): S5, 2001. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 6, 2014 | |
| Unrelease | Yes | |
| Release | Feb 7, 2014 | |
| Reset | Mar 20, 2014 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 6, 2014 | Yes | |||
| Feb 7, 2014 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mar 20, 2014 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |