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 : October 17, 2018

Sponsor:

Collaborators:

Brigham and Women's Hospital

Massachusetts General Hospital

Information provided by (Responsible Party):

F. Stephen Hodi, MD, Dana-Farber Cancer Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Melanoma	Biological: Autologous, lethally irradiated melanoma cells	Phase 1

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.

Study Design


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
Actual Study Start Date :	October 16, 2003
Actual Primary Completion Date :	September 2016
Estimated Study Completion Date :	February 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Melanoma

MedlinePlus related topics: Genes and Gene Therapy Melanoma

Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators


Principal Investigator:	F. Stephen Hodi, MD	Dana-Farber Cancer Institute

More Information


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:	October 17, 2018
Last Verified:	October 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

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