CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Aldesleukin +6 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/NCT01740557
NCT01740557Phase 2Completed

A Pilot Study of Lymphodepletion Plus Adoptive Cell Transfer With T -Cells Transduced With CXCR2 and NGFR Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma

M.D. Anderson Cancer Center·interventional·Posted Dec 4, 2012·Updated Oct 8, 2024

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes, and 5 other interventions for Metastatic Melanoma and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This phase I/II trial studies how well genetically modified therapeutic autologous lymphocytes (patient's own white blood cells) followed by aldesleukin work in treating patients with stage III melanoma or melanoma that has spread to other places in the body (metastatic). Placing chemokine (C-X-C motif) receptor 2 (CXCR2) and nerve growth factor receptor (NGFR) into lymphocytes (white blood cells) may help the body build an immune response to kill melanoma cells. Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells. Giving genetically modified therapeutic autologous lymphocytes together with aldesleukin may be a better treatment for melanoma.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 4, 2012
Enrollment StartJan 28, 2015
Primary CompletionApr 21, 2023
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 13.6 years ago

Interventions

Aldesleukinbiological

Given IV

CXCR2-transduced Autologous Tumor Infiltrating Lymphocytesbiological

Given IV

Cyclophosphamidedrug

Given IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

NGFR-transduced Autologous T Lymphocytesbiological

Given IV

Quality-of-Life Assessmentother

Ancillary studies