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

NCT ID: NCT00809588

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-16
• Study Completion Date: 2020-02-25

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.

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Melanoma Vaccine

GM-CSF Vaccine

Group Type: EXPERIMENTAL

Autologous, lethally irradiated melanoma cells

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

F. Stephen Hodi, MD

Melanoma Disease Center Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

F. Stephen Hodi, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

03-218

Identifier Type: -

Identifier Source: org_study_id