NCT00107159CompletedPhase 2
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
Jonsson Comprehensive Cancer Center2 sites in 1 country37 target enrollmentStarted: January 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
Secondary Outcomes
- Immune response
- Safety
Investigators
Study Sites (2)
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