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Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells (DCVaccineMel)

Primary Purpose

Metastatic Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous tumor cells plus dendritic cells
GM-CSF
Sponsored by
Hoag Memorial Hospital Presbyterian
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring autologous tumor cell vaccine, metastatic melanoma, sargramostim (GM-CSF)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hoag Memorial Hospital Presbyterian

Outcomes

Primary Outcome Measures

event-free survival [death or disease progression]

Secondary Outcome Measures

Overall survival

Full Information

First Posted
July 28, 2009
Last Updated
July 13, 2016
Sponsor
Hoag Memorial Hospital Presbyterian
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1. Study Identification

Unique Protocol Identification Number
NCT00948480
Brief Title
Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells
Acronym
DCVaccineMel
Official Title
Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hoag Memorial Hospital Presbyterian

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
autologous tumor cell vaccine, metastatic melanoma, sargramostim (GM-CSF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Autologous tumor cells plus dendritic cells
Intervention Description
A series of 8 vaccinations are administered over 6 months
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Other Intervention Name(s)
Sargramostim
Intervention Description
500 mcg
Primary Outcome Measure Information:
Title
event-free survival [death or disease progression]
Time Frame
5.5 years after treatment initation
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5.5 years after treatment initation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O Dillman, MD
Organizational Affiliation
Hoag Memorial Hospital Presbyterian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19538053
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.
Results Reference
result
PubMed Identifier
31406564
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.
Results Reference
derived
PubMed Identifier
29510745
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.
Results Reference
derived

Learn more about this trial

Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

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