The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma

NCT ID: NCT00626860

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2008-09-10

Brief Summary

This study aims to determine if the vacccine can be used safely in patients with advanced melanoma (cancer of the pigment cells) and whether the cells in this vaccine are capabale of producing immune responses against your own cancer.

Detailed Description

To assess the toxicity associated with vaccination of melanoma patients with dendritic cell (DC)/tumor fusions. To determine if cellular and humoral immunity can be induced by serial vaccination with DC/tumor fusions cells. To determine if vaccination DC/tumor fusions results in a tumor response.

Conditions

Metastatic Melanoma

Study Design

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

Interventions

DC/tumor fusion vaccine

SC vaccinations administered to each patient at 3-week intervals for 2-3 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment
• Patients must be at least 18 years old
• Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy
• Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study.
• Labs: WBC >_ 2.0 x 10x3/uL, Bilirubin <_2.0 mg/dL, Creatine <_ 2.0mg/dL
• Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented
• All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

• Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry
• Patients must not have received chemotherapy for three weeks prior to the first vaccination
• Patients must be without evidence of active CNS disease
• Patients must not have clinically significant autoimmune disease
• Patients must be HIV negative
• Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
• Patients requiring corticosteroids for either melanoma related or co-morbid illness

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

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Avigan

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Avigan, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

BIDMC

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

DCMEL-003-00

Identifier Type: -

Identifier Source: secondary_id

2001P001112

Identifier Type: -

Identifier Source: org_study_id