Know Cancer

forgot password

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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Melanoma

Thank you

Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

screening/baseline, treatment period and follow-up

Safety Issue:


Principal Investigator

David Avigan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2000

Completion Date:

November 2008

Related Keywords:

  • Metastatic Melanoma
  • melanoma
  • Melanoma



BIDMC Boston, Massachusetts  02215