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Metastatic MelanomaPhase 2DCVaccineMelNCT00948480

Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

A Phase 2 study testing Autologous tumor cells plus dendritic cells and GM-CSF in people with Metastatic Melanoma, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Autologous tumor cells plus dendritic cells and GM-CSF
Type of treatment
Vaccines
How many people
56 participants
Where
1 siteUnited States
Study dates
Oct 2000to Sep 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

Other trials in United States

About this study

Official title: Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma

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.

Read the 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.

Being tested
Autologous tumor cells plus dendritic cells, GM-CSF
Keywords
autologous tumor cell vaccine, metastatic melanoma, sargramostim (GM-CSF)
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous tumor cells plus dendritic cellsBiological

    A series of 8 vaccinations are administered over 6 months

  • GM-CSFDrug

    Also called Sargramostim

    500 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. event-free survival [death or disease progression]

    Measured: 5.5 years after treatment initation

Secondary outcomes (1)

  1. Overall survival

    Measured: 5.5 years after treatment initation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2009 (estimated)
  2. Study startOct 2000
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00948480
Sponsor's protocol ID
DC Melanoma
Acronym
DCVaccineMel
Status last verified
Jul 2016
First submitted
28 Jul 2009
Last updated
15 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19538053

  • 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.

    PubMed 31406564

  • 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.

    PubMed 29510745

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous tumor cells plus dendritic cells and GM-CSF in people with Metastatic Melanoma, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

event-free survival [death or disease progression] (time frame: 5.5 years after treatment initation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00948480, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2016.

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