CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Aldesleukin +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02027935
NCT02027935Phase 2Completed

Phase II Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4 for Patients With Metastatic Melanoma

M.D. Anderson Cancer Center·interventional·Posted Jan 6, 2014·Updated Oct 8, 2024

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, Autologous CD8+ Melanoma Specific T Cells, and 3 other interventions for Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This phase II trial studies the side effects and how well white blood cells taken from person's own (autologous) cluster of differentiation (CD)8+ antigen-specific T cells, cyclophosphamide, aldesleukin, and ipilimumab work in treating patients with melanoma that has spread to another place in the body. Autologous CD8+ antigen-specific T cells are white blood cells that are designed in the laboratory to find melanoma cells and may kill them. Biological therapies, such as aldesleukin, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving autologous CD8+ antigen-specific T cells with cyclophosphamide, aldesleukin, and ipilimumab may be an effective treatment for patients with metastatic melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 6, 2014
Enrollment StartJan 22, 2015
Primary CompletionApr 12, 2024
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 12.5 years ago

Interventions

Aldesleukinbiological

Given SC

Autologous CD8+ Melanoma Specific T Cellsbiological

Given IV

Cyclophosphamidedrug

Given IV

Ipilimumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies