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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00107159 |
RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma.
Condition | Intervention | Phase |
Melanoma (Skin) |
Drug: autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine |
Phase II |
MedlinePlus related topics: | Cancer Melanoma |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma |
Estimated Enrollment: | 37 |
Study Start Date: | January 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). The PBMCs are cultured with sargramostim (GM-CSF) and interleukin-13 for the production of dendritic cells. The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines (IDD-3) to produce the vaccine.
Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0, 2, 4, 6, 8, 10, 16, and 22 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 2, 10, 18, and 26 weeks.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary cutaneous or unknown primary melanoma, including 1 of the following stages:
Stage IIIB or IIIC disease
Stage IV disease
Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b)
At least 1 measurable or evaluable lesion
Progressive disease, as defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
No history of autoimmune disease
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |||||
Jonsson Comprehensive Cancer Center at UCLA | |||||
Los Angeles, California, United States, 90095-1781 |
Jonsson Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Antoni Ribas, MD | Jonsson Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000422429, UCLA-0408080-01, IDM-DC-MEL-202 |
First Received: | April 5, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00107159 |
Health Authority: | United States: Federal Government |
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