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

Metastatic Melanoma Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

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