The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma

NCT00459069 | Completed Phase 1 DMC

• 1 other identifier: 03-240
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer cells have unique markers that distinguish them from normal cells of the body. These markers can potentially serve as targets for the immune system. Dendritic cells are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.

Conditions

Multiple Myeloma

Keywords

tumor vaccine; GM-CSF

Outcome Measures

Primary Outcomes (1)

• To assess the toxicity associated with vaccination of patients multiple myeloma with dendritic cell(DC)/tumor cell fusions co-administered with GM-CSF.

  5 years

Secondary Outcomes (2)

• To determine whether evidence of tumor specific cellular and humoral immunity can be induced by serial vaccination with DC/tumor cell fusion cells co-administered with GMCSF

  5 years

• to determine if vaccination with DC/tumor cell fusions co-administered with GM-CSF results in clinical disease response.

  5 years

Interventions

Dendritic Cell Tumor Fusion Vaccine BIOLOGICAL

Vaccine administered on weeks 0, 3 and 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of multiple myeloma: Stage I not requiring initiation of chemotherapy; Stage I, II or III patients felt to be clinically stable and having received at least one prior chemotherapy regimen
• Measurable disease as defined by a history of an elevated M component in plasma or urine or free kappa.lambda light chains in serum
• years of age or older
• ECOG Performance Status of 0-1 with a greater than nine week life expectancy
• \> 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
• Laboratory results within ranges outlined in protocol
• Negative pregnancy test and adequate contraception method(s) must be documented

You may not qualify if:

• History of clinically significant venous thromboembolism
• Received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
• Chemotherapy or radiation therapy 4 weeks prior to the first vaccine
• Clinically significant autoimmune disease
• HIV positive
• Serious intercurrent illness
• Taking systemic corticosteroids within 4 weeks of treatment with study drug

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• David Avigan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: July 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2009
• Last Updated: January 12, 2010

Record last verified: 2010-01

Locations

US (1)