Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00107159|
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : November 6, 2013
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 or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine||Phase 2|
- Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor control, in patients with unresected stage IIIB or IIIC or stage IV melanoma.
- Determine the immunologic activity of this vaccine, as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides, in these patients.
- Determine the safety of this vaccine, as measured by the incidence and severity of adverse events, in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Masking:||None (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|
|Study Start Date :||January 2005|
|Actual Study Completion Date :||September 2010|
- Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
- Immune response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107159
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Antoni Ribas, MD||Jonsson Comprehensive Cancer Center|