Phase 1
Completed N=5
Dendritic Cell Vaccination in Patients With Advanced Melanoma
Source: ClinicalTrials.gov NCT03092453 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Dec 2024
Primary outcomePrimary: Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. — 0; 0; 0; 0 percent of CD8+ T cells
Summary
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines). |
3; 2 | — |
| SECONDARY Clinical Response to the mDC3/8 Vaccine(s) |
2; 3 | — |
| SECONDARY Time to Progression Post-mDC3/8 Vaccine Administration |
113; NA; NA; NA; 80 | — |
| SECONDARY Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide. |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed stage III and stage IV M1a/M1b/M1c melanoma. Measurable disease is not required for enrollment eligibility and patients with completely resected disease are permitted.
- Male or female patients age greater than or equal to 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator):
- WBC (white blood cells) >3,000/mm3
- Hg (hemoglobin) greater than or equal to 9.0 gm/dl
- Platelets >75,000/mm3
- Serum Bilirubin < 2.0 mg/dl
- Serum Creatinine < 2.0 mg/dl
- Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
- Provide written informed consent.
Exclusion Criteria
- Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilimumab, anti-PD1, or BRAF + MEK inhibitor combination) is permitted.
- Active untreated CNS (central nervous system) metastasis
- Active infection
- Prior malignancy (except non-melanoma skin cancer) within 3 years
- Pregnant or nursing (lactating) women
- Concurrent treatment with high-dose systemic corticosteroids; local (inhaled or topical) steroids are permitted
- Known allergy to eggs
- Prior history of uveitis or autoimmune inflammatory eye disease
- Known positivity for hepatitis B antibody, hepatitis C antibody, or HIV antibody
Data sourced from ClinicalTrials.gov (NCT03092453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.