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NCT01876212 · ClinicalTrials.gov registry record · Phase 2
Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma
A Phase 2 study of Metastatic Melanoma, sponsored by Walter J. Storkus.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01876212 is a Phase 2 study of Metastatic Melanoma that has completed, run by Walter J. Storkus. The registered enrollment target is 15 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01876212, a Phase 2 study of Metastatic Melanoma, has completed, sponsored by Walter J. Storkus.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Current therapeutic approaches available for patients with advanced-stage melanoma remain inadequate, and existing approaches including those involving immunotherapy with cytokines and/or targeted strategies have resulted in disappointingly low rates of durable and complete responses. Correcting immune dysfunction in advanced-stage melanoma patients using tyrosine-kinase inhibitor (TKI) such as dasatinib is proposed to relicense the patient's immune system to respond optimally to specific immunization. The integration of antigens expressed by tumor-associated blood vessel cells provides a means to selectively target the genetically-/antigenically-heterogeneous population of tumor cells in the advanced-stage melanoma patient. This is a single-center, prospective randomized Phase 2 trial evaluating the activity, safety and immune effects of dasatinib given in combination with an autologous type-1 polarized Dendritic Cell (αDC1) vaccine. The current trial represents a randomized Phase 2 study to determine the activity and safety of intradermal (id) administration of αDC1s loaded with a mixture of six TBVA-derived peptides at the time of, or immediately after, an initial therapy cycle with the TKI dasatinib. Dasatinib will be administered at the standard dose and schedule recommended by the FDA (70 mg BID). The autologous type-I DC vaccine will be administered either prior to, or concomitant with, the initiation of dasatinib administration. All patients will receive dasatinib at a starting dose of 70 mg twice daily by mouth in the outpatient setting approximately every 12 hours, at the same time each day. The DC vaccine will be administered by a single intradermal injection of approximately 10e7 cells, with all the DCs being administered on days 1 and 15 of every cycle on an outpatient basis in the University of Pittsburgh Clinical and Translational Research Center (UPCI-CTRC). Patients on Arm A will start dasatinib administration on cycle 2, day 1 (week 5), while t
Conditions Studied
Interventions
- DRUG Dasatinib
- BIOLOGICAL DC vaccine
Study Locations (1)
Pennsylvania
- Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-05-16 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01876212
The ClinicalTrials.gov registry entry for NCT01876212 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (82% lower). The listed sponsor is Walter J. Storkus, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Dasatinib is the first listed.
NCT01876212 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01876212 about?
NCT01876212 is a clinical study titled "Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma". Current therapeutic approaches available for patients with advanced-stage melanoma remain inadequate, and existing approaches including those involving immunotherapy with cytokines and/or targeted strategies have resulted in disappointingly low rates of durable and complete responses. Correcting imm...
What is the current status of trial NCT01876212?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2014-05-16. Estimated completion is 2019-07-31.
What conditions does trial NCT01876212 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT01876212?
The interventions under investigation include: Dasatinib (DRUG), DC vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01876212?
This trial is sponsored by Walter J. Storkus, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01876212 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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