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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

Must not have

Patients needing chronic, immunosuppressive systemic steroids

Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average of 10 months follow-up

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need to take steroids every day for my immune system.

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I do not have any active infections, bleeding disorders, or major illnesses affecting my heart, lungs, or immune system.

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I have an autoimmune disease and take medication to suppress my immune system.

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I do not have more than 3 untreated brain metastases or swelling around tumors.

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I do not have more than 3 untreated brain metastases, none larger than 1 cm or causing swelling.

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I understand and can agree to the study's requirements.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth

Secondary study objectives

Number of Participants With Objective Response (OR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2490

0 / 10Eligibility criteria met