The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00626860 |
Recruitment Status :
Completed
First Posted : February 29, 2008
Last Update Posted : March 28, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Melanoma | Biological: DC/tumor fusion vaccine | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma |
Study Start Date : | July 2000 |
Actual Primary Completion Date : | January 2002 |
Actual Study Completion Date : | September 10, 2008 |

- Biological: DC/tumor fusion vaccine
SC vaccinations administered to each patient at 3-week intervals for 2-3 doses
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626860
United States, Massachusetts | |
BIDMC | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | David Avigan, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | David Avigan, Professor of Medicine, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00626860 |
Other Study ID Numbers: |
2001P001112 DCMEL-003-00 |
First Posted: | February 29, 2008 Key Record Dates |
Last Update Posted: | March 28, 2017 |
Last Verified: | March 2017 |
melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |