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

Beth Israel Lahey Health

Status and phase

Completed

Phase 2

Phase 1

Conditions

Metastatic Melanoma

Treatments

Biological: DC/tumor fusion vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00626860

DCMEL-003-00

2001P001112

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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