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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00626860
Other study ID # 2001P001112
Secondary ID DCMEL-003-00
Status Completed
Phase Phase 1/Phase 2
First received February 21, 2008
Last updated March 24, 2017
Start date July 2000
Est. completion date September 10, 2008

Study information

Verified date March 2017
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 10, 2008
Est. primary completion date January 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States BIDMC Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the toxicity, cellular and humoral immunity and tumor response in patient with melanoma receiving the DC/tumor fusion vaccine screening/baseline, treatment period and follow-up
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