Clinical trial · Interventional
Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells
Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous tumor cells plus dendritic cells | Biological | — | UNRESOLVED |
| GM-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- event-free survival [death or disease progression]
- timeFrame
- 5.5 years after treatment initation
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5.5 years after treatment initation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTDillman 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. PMID 19538053
- DERIVEDDillman 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. PMID 31406564
- DERIVEDDillman 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. PMID 29510745