NCT00948480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

6.9 years

First QC Date

July 28, 2009

Last Update Submit

July 13, 2016

Conditions

Metastatic Melanoma

Keywords

autologous tumor cell vaccinemetastatic melanomasargramostim (GM-CSF)

Outcome Measures

Primary Outcomes (1)

  • event-free survival [death or disease progression]

    5.5 years after treatment initation

Secondary Outcomes (1)

  • Overall survival

    5.5 years after treatment initation

Interventions

Autologous tumor cells plus dendritic cellsBIOLOGICAL

A series of 8 vaccinations are administered over 6 months

GM-CSFDRUG

500 mcg

Also known as: Sargramostim

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Related Publications (3)

  • 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.

    PMID: 19538053RESULT

  • 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.

    PMID: 31406564DERIVED

  • 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.

    PMID: 29510745DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factorsargramostim

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Robert O Dillman, MD

    Hoag Memorial Hospital Presbyterian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

October 1, 2000

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations

US(1)