Multiple Myeloma Clinical Trial
Official title:
The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma
Verified date | January 2010 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 2009 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - 18 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 Exclusion Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Brigham and Women's Hospital, Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | 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 | No | |
Secondary | to determine if vaccination with DC/tumor cell fusions co-administered with GM-CSF results in clinical disease response. | 5 years | No |
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