Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Stimulating Factor (GMSF)
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ClinicalTrials.gov Identifier: NCT00809588 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 17, 2008
Last Update Posted
: February 1, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Biological: Autologous, lethally irradiated melanoma cells | Phase 1 |
- 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase IB Study of Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | September 2016 |
Estimated Study Completion Date : | March 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Melanoma Vaccine
GM-CSF Vaccine
|
Biological: Autologous, 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
|
- 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 ]
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Uncontrolled active infection
- Pregnancy or nursing mothers
- Evidence of infection with Human Immunodeficiency Virus, Hepatitis B or C

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809588
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | F. Stephen Hodi, MD | Dana-Farber Cancer Institute |
Responsible Party: | F. Stephen Hodi, MD, Melanoma Disease Center Director, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00809588 History of Changes |
Other Study ID Numbers: |
03-218 |
First Posted: | December 17, 2008 Key Record Dates |
Last Update Posted: | February 1, 2018 |
Last Verified: | January 2018 |
Keywords provided by F. Stephen Hodi, MD, Dana-Farber Cancer Institute:
vaccination GM-CSF autologous irradiated |
Additional relevant MeSH terms:
Melanoma Nevi and Melanomas Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Nerve Tissue Vaccines Immunologic Factors Physiological Effects of Drugs |