Clinical trial NCT00948480: Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells
Official title: Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Melanoma
Keywords: autologous tumor cell vaccine
metastatic melanoma
sargramostim (GM-CSF)
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous tumor cells that had been established as short-term cell lines, in conjunction with their own dendritic cells (DC) and granulocyte macrophage colony-stimulating factor \[GM-CSF\]. Eligible patients had regionally recurrent and/or distant metastatic cancer.

Detailed description: Patients were stratified by whether they had no measurable disease \[NMD\] at the time of treatment (usually because of surgical resection of metastases), or whether they had objectively measurable disease (OMD) by physical examination or radiologic scans per response evaluation criteria in solid tumors (RECIST criteria). Key endpoints were the results of delayed type hypersensitivity (DTH) skin testing to their own irradiated tumor cells, event-free survival \[death or disease progression\], overall survival, and objective tumor regression in patients who have measurable disease at the time vaccine therapy was initiated. This study was activated in the fall of 2000, and closed to accrual in June 2007.

Eligibility criteria: Inclusion Criteria:

* Recurrent or metastatic melanoma as defined by stage IV disease (distant metastases), or any recurrent melanoma manifested by lymph node metastases or soft tissue nodules
* ECOG Performance status of 0-2
* Satisfactory medical condition for treatment in a phase I-II trial of anticancer therapy
* Age \> 16 years
* Venous access for leukopheresis procedure to obtain peripheral blood lymphocytes to generate dendritic cells.
* Serum pregnancy test must be negative for women of childbearing potential.

Exclusion Criteria:

* Active central nervous system metastases
* Known autoimmune disease or disease process that involves the use of immunosuppressive therapy.
* Underlying cardiac disease associated with New York Heart Association class III or IV function, or unstable angina related to atherosclerotic cardiovascular disease.
* Ongoing transfusion requirements, no significant hepatic or renal dysfunction, creatinine \< 2.0 mg/dl, bilirubin \< 2.0 mg/dl, albumin \> 3.0 mg/dl, hematocrit \> 25, platelets \> 100,000.
* Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis.

Primary outcomes:
measure: event-free survival [death or disease progression]
timeFrame: 5.5 years after treatment initation
Secondary outcomes:
measure: Overall survival
timeFrame: 5.5 years after treatment initation
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
Study officials:
affiliation: Hoag Memorial Hospital Presbyterian
name: Robert O Dillman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dillman RO, Selvan SR, Schiltz PM, McClay EF, Barth NM, DePriest C, de Leon C, Mayorga C, Cornforth AN, Allen K. Phase II trial of dendritic cells loaded with antigens from self-renewing, proliferating autologous tumor cells as patient-specific antitumor vaccines in patients with metastatic melanoma: final report. Cancer Biother Radiopharm. 2009 Jun;24(3):311-9. doi: 10.1089/cbr.2008.0599.
citation: Dillman RO, Cornforth AN, McClay EF, Depriest C. Patient-specific dendritic cell vaccines with autologous tumor antigens in 72 patients with metastatic melanoma. Melanoma Manag. 2019 May 31;6(2):MMT20. doi: 10.2217/mmt-2018-0010.
citation: Dillman RO, Cornforth AN, Nistor GI, McClay EF, Amatruda TT, Depriest C. Randomized phase II trial of autologous dendritic cell vaccines versus autologous tumor cell vaccines in metastatic melanoma: 5-year follow up and additional analyses. J Immunother Cancer. 2018 Mar 6;6(1):19. doi: 10.1186/s40425-018-0330-1.