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CompletedNCT00809588Updated Aug 21, 2024

Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Stimulating Factor (GMSF)

A Phase 1 interventional study of Autologous, lethally irradiated melanoma cells in Melanoma, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 2 months after the study started (first participant enrolled Oct 2003, registered Dec 2008).
Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to see if the proposed therapy will delay or stop the progression of the participants skin cancer. This study is being done because there are currently no treatments which have been shown convincing to treat disease which has progressed. This research study is designed to evaluate the immunologic effects and clinical side effects of giving vaccines to patients that are made from their own skin cancer cells.

Read the detailed description
  • The vaccines created from the participants melanoma cells are scheduled to be given to the participants on days 1, 8, 15, 29 and every two weeks after until the supply of vaccine has run out. The amount of vaccine is dependent on the total amount of cells yielded when the tumor is processed and treated. It is hoped that participants will receive at least six vaccines.
  • The vaccines will be administered in two injections that will be placed underneath the participants skin. The two injections will be given at the same place on the body.
  • If tumor sample yields enough cells, participants will also receive an injection of non-transduced irradiated melanoma cells. The purpose of this is to measure the amount of reaction of the participants immune system occuring created by the vaccine.
  • If either the vaccine site or DTH placement site has shown a reaction, a punch-biopsy will be taken. This will consist of a small piece of skin tissue removed under local anesthesia.
  • With vaccine #5, participants will receive a second DTH injection. Two days after the vaccine and DTH injection, punch biopsies will be taken of both sites.
  • At week 10 of treatment (or earlier if necessary), participants will undergo a chest, abdomen and pelvic CT scan. The physician may also have participants undergo a brain MRI if indicated at this time.
02

Conditions studied

  • Melanoma

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Keywords

  • vaccination
  • GM-CSF
  • autologous
  • irradiated
03

In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's enrollment of 84 is above the median of 38 across 2,400 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 832 studies on the registry; 120 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Browse Dana-Farber Cancer Institute studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Stage III patients must have: A) Histologically documented melanoma B) Lymphadenopathy of at least 2cm in greatest diameter by physical exam or CT scan in a region draining a known or suspected primary melanoma or in transit metastatic disease of at least 2cm in greatest diameter by physical exam or CT in a region draining a known primary melanoma C) refused, not eligible, or failed adjuvant therapy with high dose a-interferon D) must be able to have all measurable disease removed at time of tumor harvest
  • Stage IV patients must have histologically documented metastatic melanoma
  • ECOG Performance Status 0 or 1
  • Estimated life expectancy of 6 months or greater
  • 18 years of age or older
  • Signed Informed Consent
  • Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy
  • Greater than 6 months since bone marrow or peripheral blood stem cell transplant

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled active infection
  • Pregnancy or nursing mothers
  • Evidence of infection with Human Immunodeficiency Virus, Hepatitis B or C
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Melanoma Vaccine

    GM-CSF Vaccine

    Biological: Autologous, lethally irradiated melanoma cells

Interventions

  • BiologicalAutologous, lethally irradiated melanoma cells

    Engineered to secrete human granulocyte-macrophage stimulating factor. Given on days 1, 8, 15, 29 and every two weeks after until the supply of vaccine has run out

06

What researchers measure

Primary outcomes

  1. To determine the doses of lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete CM-CSF that can be manufactured in stage III melanoma patients.

    Time frame: 7 years

Secondary outcomes

  1. To determine the safety and biologic activity of vaccination with lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete GM-CSF

    Time frame: 7 years

  2. To determine the two-year survival of stage IV melanoma patients vaccinated with lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete GM-CSF

    Time frame: 7 years

  3. To determine more fully the safety and biologic activity of vaccination with lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in stage IV melanoma patients

    Time frame: 7 years

07

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2003 to primary completion in Sep 2016, 155 months.

Of 171 non-industry phase 1 interventional studies under Melanoma, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 89. This study's 155 months is above that.

Counting every sponsor, half of 346 studies reached it within 49 months; a quarter within 32 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2008
First posted
Dec 17, 2008
StartActual
Oct 16, 2003
Primary completionActual
Sep 2016
CompletionActual
Feb 25, 2020
Last update
Aug 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00809588
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
Responsible party
F. Stephen Hodi, MD (Melanoma Disease Center Director, Dana-Farber Cancer Institute) — Principal investigator
First posted
Dec 17, 2008
Start date
Oct 16, 2003
Primary completion
Sep 2016
Completion
Feb 25, 2020
Last update
Aug 21, 2024

Study contacts

F. Stephen Hodi, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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