The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Beth Israel Deaconess Medical Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
Genzyme
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00626860
First received: February 21, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Melanoma |
Biological: DC/tumor fusion vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma |
Resource links provided by NLM:
Further study details as provided by Beth Israel Deaconess Medical Center:
Primary Outcome Measures:
- To assess the toxicity, cellular and humoral immunity and tumor response in patient with melanoma receiving the DC/tumor fusion vaccine [ Time Frame: screening/baseline, treatment period and follow-up ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2000 |
| Estimated Study Completion Date: | November 2008 |
| Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: DC/tumor fusion vaccine
SC vaccinations administered to each patient at 3-week intervals for 2-3 doses
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626860
Locations
| United States, Massachusetts | |
| BIDMC | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Genzyme
Investigators
| Principal Investigator: | David Avigan, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | David Avigan, MD, BIDMC |
| ClinicalTrials.gov Identifier: | NCT00626860 History of Changes |
| Other Study ID Numbers: | 2001-P-01112/1, DCMEL-003-00 |
| Study First Received: | February 21, 2008 |
| Last Updated: | February 21, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Beth Israel Deaconess Medical Center:
|
melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 21, 2013