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Cell Therapy

Lymphodepletion + Adoptive Cell Transfer with High Dose IL-2 for Melanoma

N/A

Waitlist Available

Led By Amod Sarnaik, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Residual measurable disease after resection of target lesion(s) for TIL growth

Patients must have a positive screening Epstein-Barr virus (EBV) antibody titre on screening test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average of 10 months follow-up

Awards & highlights

Study Summary

This trial is testing whether a certain type of immunotherapy is effective and has few side effects for treating melanoma.

Who is the study for?

This trial is for adults with advanced melanoma, either untreated or previously treated. They can have up to 3 brain metastases if certain conditions are met. Participants need good organ function and a performance status indicating they're mostly active. Pregnant women, those with severe infections, blood clotting issues, autoimmune diseases needing steroids, or significant psychiatric illness cannot join.Check my eligibility

What is being tested?

The study tests a combination of treatments: lymphodepletion (weakening the immune system), adoptive cell transfer (injecting immune cells), high dose IL-2 (a substance that activates immune cells), and surgery on patients with metastatic melanoma to see if this improves treatment outcomes.See study design

What are the potential side effects?

Potential side effects include reactions from weakening the immune system like increased infection risk; symptoms from high-dose IL-2 such as fever and low blood pressure; complications from surgery; and general fatigue or discomfort due to treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I still have visible cancer after surgery to remove some of it for treatment.

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I have tested positive for Epstein-Barr virus antibodies.

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My melanoma cannot be removed by surgery and is either stage IV or advanced stage III.

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My kidney, liver, and blood tests are within normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average of 10 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average of 10 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and average of 10 months follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth

Secondary outcome measures

Number of Participants With Objective Response (OR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: TIL With High Dose IL-2Experimental Treatment4 Interventions

Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours. Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days. Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused. Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surgery

2000

Completed Phase 3

~2550

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,473 Total Patients Enrolled

43 Trials studying Melanoma

3,199 Patients Enrolled for Melanoma

Amod Sarnaik, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

3 Previous Clinical Trials

41 Total Patients Enrolled

3 Trials studying Melanoma

41 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.

To what extent is the sample size of this experimental protocol?

"At present, no more participants are being recruited for this trial. The original posting date was October 20th 2009 and the latest update happened on August 15th 2022. If you're looking to join another study, there are 767 trials seeking patients with metastatic melanoma and 841 studies requiring High Dose IL-2 volunteers."

Answered by AI

Has any other research investigated the efficacy of High Dose IL-2?

"As of now, 841 clinical trials are employing High Dose IL-2 in their research with 156 tests being conducted at the third phase. Most studies take place within Philadelphia, Pennsylvania but there exists a grand total of 28059 sites where this kind of experimentation is taking place."

Answered by AI

Are enrollees being accepted for this research endeavor?

"The data displayed on clinicaltrials.gov demonstrate that this medical trial is no longer recruiting candidates, as the last update was dated August 15th 2022. Despite that fact, there are still 1608 other trials actively searching for participants at present."

Answered by AI

What conditions have been treated using High Dose IL-2?

"High Dose Interleukin-2 is a widely used course of treatment for melanoma, but it also has the potential to help patients with multiple sclerosis, mixed cell lymphoma, and acute myelocytic leukemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma

2009. "Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01005745.