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CAR T-cell Therapy

CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes for Melanoma

Phase 1 & 2

Waitlist Available

Led By Rodabe N Amaria

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing a new treatment for melanoma that has spread to other places in the body. The treatment involves genetically modifying the patient's own white blood cells to make them better at killing melanoma cells, and then giving the patient aldesleukin to help stimulate the cells.

Eligible Conditions

Metastatic Melanoma
Cutaneous Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events defined as possible grade 3 or worse toxicities

Response assessed by immune-related response criteria and evaluated by positron emission tomography or computed tomography imaging

Secondary outcome measures

Amount of CXCL8 cytokine

Amount of CXCR2 cytokine

Number of CXCR2 transduced cells

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (genetically modified T-cells, high-dose aldesleukinExperimental Treatment7 Interventions

Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Patients then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Aldesleukin

2012

Completed Phase 4

~1620

CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes

2015

Completed Phase 2

~10

NGFR-transduced Autologous T Lymphocytes

2015

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,311 Total Patients Enrolled

102 Trials studying Melanoma

25,304 Patients Enrolled for Melanoma

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,871 Total Patients Enrolled

557 Trials studying Melanoma

193,179 Patients Enrolled for Melanoma

Rodabe N AmariaPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

148 Total Patients Enrolled

5 Trials studying Melanoma

148 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why did researchers design this clinical trial?

"The purpose of this clinical trial, which will take place over the course of 1 year, is to study the incidence of adverse events in patients. Outcomes that will be measured include: number of NGFR transduced cells, amount of CXCR2 cytokine, and number of CXCR2 transduced cells. Data analysis methods include regression analysis and logistic regression."

Answered by AI

How many research subjects are needed for this project?

"While this study is not currently looking for more participants, it may be helpful to know that there are 861 other studies actively recruiting patients with skin cancer and 955 studies enrolling CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes."

Answered by AI

What is the most popular disease that CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes helps to cure?

"While CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes are most often used to help patients with multiple sclerosis, this treatment can also be useful for those suffering from leukemia, myelocytic, acute, retinoblastoma, and histiocytic lymphoma."

Answered by AI

Are there other ongoing clinical trials using CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes?

"Currently, there are 955 clinical trials studying CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes with 168 in Phase 3. While several of the trials for CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes are running out of in Philadelphia, Pennsylvania, there are 28857 locations running studies for CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes."

Answered by AI

Are recruitment efforts ongoing for this particular research project?

"This clinical trial, as indicated on the government-run website clinicaltrials.gov, is not currently recruiting patients. The study was first posted on January 28th, 2015 and was last updated on August 18th, 2022. There are 1,816 other trials enrolling participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma

2015. "Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01740557.