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The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma

Primary Purpose

Metastatic Melanoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DC/tumor fusion vaccine

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

BIDMC

Outcomes

Primary Outcome Measures

To assess the toxicity, cellular and humoral immunity and tumor response in patient with melanoma receiving the DC/tumor fusion vaccine

Secondary Outcome Measures

Full Information

NCT ID

NCT00626860

First Posted

February 21, 2008

Last Updated

March 24, 2017

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Genzyme, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00626860

Brief Title

The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma

Official Title

The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

July 2000 (undefined)

Primary Completion Date

January 2002 (Actual)

Study Completion Date

September 10, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Melanoma

Keywords

melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

DC/tumor fusion vaccine

Intervention Description

SC vaccinations administered to each patient at 3-week intervals for 2-3 doses

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Avigan, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

BIDMC

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma

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