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Chemotherapy

Adoptive Cell Transfer + Immunotherapy for Melanoma

Phase 2

Waitlist Available

Led By Rodabe N. Amaria, MD

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

Patients must be HLA-A2 for cohort A

Patients must have ECOG performance status 0, 1 or 2 and/or KPS > 50

Must not have

Has had prior B-RAF or MEK targeted therapy within 7 days prior to the start of the lymphodepletion regimen (Cohort A and Cohort B)

Patients with rapidly advancing parenchymal brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up clinical evaluation during first 70 days, ct scan at 6-8 weeks (+/- 7 days) after cell infusion.

Awards & highlights

No Placebo-Only Group

Approved for 20 Other Conditions

Summary

This trial is studying three different combinations of treatment as compared to treatment with T cells and high dose IL-2 alone in order to find which combination is the most effective in treating patients with melanoma.

Who is the study for?

This trial is for patients over 12 years old with metastatic melanoma, including those who have not responded well to B-RAF inhibitors or have brain lesions. Participants must be in good health overall, with proper kidney function and no severe illnesses affecting the heart, lungs, or immune system. Pregnant women and individuals with rapid disease progression or significant psychiatric conditions are excluded.

What is being tested?

The study tests whether adding dendritic cell immunization to T-cell therapy improves the persistence of infused T cells in fighting melanoma compared to T-cell therapy alone. It also examines if this combination enhances anti-tumor activity and migration of T cells to tumor sites across different cohorts.

What are the potential side effects?

Potential side effects include reactions from high doses of interleukin-2 (IL-2), such as flu-like symptoms, low blood pressure, nausea; effects from chemotherapy like hair loss, mouth sores; risks associated with adoptive cell transfer may involve fever and chills.

Eligibility Criteria

Inclusion Criteria

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

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I am HLA-A2 positive.

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I can care for myself and am up more than 50% of my waking hours.

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My melanoma has spread and can be measured.

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I can sit up by myself or with help.

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I am on a B-RAF inhibitor but my cancer did not improve or got worse.

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My melanoma has spread or is in stage III.

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I am 12 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I have not taken B-RAF or MEK inhibitors in the last 7 days.

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My cancer has spread to my brain and is getting worse quickly.

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My cancer responded well to B-RAF treatment.

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I am not currently on B-RAF treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ clinical evaluation during first 70 days, ct scan at 6-8 weeks (+/- 7 days) after cell infusion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~clinical evaluation during first 70 days, ct scan at 6-8 weeks (+/- 7 days) after cell infusion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and clinical evaluation during first 70 days, ct scan at 6-8 weeks (+/- 7 days) after cell infusion. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Longitudinal Immune Response in Cohort D

Objective Response (OR)

Overall response rate (ORR) of TIL generated with the TIL 3.0 pre-REP methodology in Cohort E

Awards & Highlights

No Placebo-Only Group

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

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Group E: Chemotherapy + IL-2 plus T-Cells + VaccineExperimental Treatment6 Interventions

Chemotherapy and IL-2 plus T-cells and the vaccine of dendritic cells received by vein (IV) about 4 hours after T-cells and again on Day 21 (+/- 7 days). Cyclophosphamide 60 mg/kg/d IV over 2 hours Days -7 and -6 (with Mesna) and Fludarabine 25 mg/m\^2 IV daily Days -5 to -1 before T cell infusion. On Day 0, up to 1.5 x 10\^11 T cells IV infusion over 30-60 minutes. Interleukin-2 12-16 hours after T cell infusion at standard dose of 720,000 IU/kg as intravenous bolus over 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26.

Group II: Group D: Leptomeningeal DiseaseExperimental Treatment2 Interventions

T-cells: 5.0x109 TIL administered on Day 1 and 10x109 TIL on Day 15. IL-2: 1.2 MIU of IL- 2 on Days 2, 4, 9, 11, 16 and 18 as tolerated. After this period, patient receives twice weekly IL-2 that will be gradually changed to weekly IL-2. After 4-6 weeks, patients switched to IL-2.

Group III: Group C: Prior Treatment with BRAF InhibitorExperimental Treatment6 Interventions

Group IV: Group B: Chemotherapy + IL-2 plus T-Cells + VaccineExperimental Treatment6 Interventions

Group V: Group A: Chemotherapy + IL-2 plus T-cellsExperimental Treatment5 Interventions

Cyclophosphamide 60 mg/kg/d by vein (IV) over 2 hours Days -7 and -6 (with Mesna) and Fludarabine 25 mg/m\^2 IV daily Days -5 to -1 before T cell infusion. On Day 0, up to 1.5 x 10\^11 T cells IV infusion over 30-60 minutes. Interleukin-2 12-16 hours after T cell infusion at standard dose of 720,000 IU/kg as intravenous bolus over 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26. Group A has been closed to new patient entry as of January 14, 2016.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

FDA approved

Aldesleukin

FDA approved

Cyclophosphamide

FDA approved

Coenzyme M

FDA approved