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Cytokine

Immunotherapy + Chemotherapy for Uveal Melanoma

Phase 1

Waitlist Available

Led By Sapna P Patel

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

Eastern Cooperative Oncology Group (ECOG)/ Zubrod performance status of 0-1

Expression of human leukocyte antigen (HLA)-A:0201 or HLA-A:2402

Must not have

Steroids (at prednisone equivalent doses > 10 mg) are not permitted 3 days prior to T cell infusion and concurrently during therapy

Patients may not be on any other treatments for their cancer aside from those included in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying autologous CD8+ T cells, which are collected from patients' blood and treated to target melanoma cells, when given with other drugs to see how well they work in treating patients with metastatic uveal melanoma.

Who is the study for?

This trial is for patients with metastatic uveal melanoma. They must have measurable disease, specific human leukocyte antigen types, and be in good physical condition (ECOG/Zubrod status of 0-1). Women who can bear children and men must use contraception. Patients should not have significant heart issues or other conditions that could complicate treatment.

What is being tested?

The trial tests a combination of treatments: autologous CD8+ T lymphocytes tailored to target melanoma cells, cyclophosphamide chemotherapy, aldesleukin biological therapy, and ipilimumab immunotherapy. The goal is to see if this mix works better for treating metastatic uveal melanoma.

What are the potential side effects?

Potential side effects include immune system reactions leading to inflammation in various organs due to ipilimumab; blood cell count changes from cyclophosphamide; fatigue; allergic reactions; and possible infection risks from the overall weakening of the immune system.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My cancer cells show specific immune system markers.

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Side effects from my previous treatments are mild or back to normal, except for those that won’t improve.

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My melanoma was confirmed by a tissue examination at the time it spread or was diagnosed as high-risk.

Exclusion Criteria

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

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I haven't taken high doses of steroids 3 days before and during T cell therapy.

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I am not on any cancer treatments not approved in this study.

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I have serious lung problems confirmed by my doctor.

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I am not pregnant, nursing, and if of childbearing potential, I agree to use effective contraception.

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I do not have a history of inflammatory bowel disease or any autoimmune diseases.

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My liver enzymes are high due to liver metastasis.

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I have serious heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Duration of clinical response (DOR)

Incidence of toxicity

Overall response rate

+4 more

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: Treatment (cyclophosphamide, T-cells, aldesleukin, ipilimumab)Experimental Treatment4 Interventions

PREPARATIVE REGIMEN: Patients receive cyclophosphamide IV over 30-60 minutes on day -2. T-CELL INFUSION: Patients receive autologous CD8+ SLC45A2-specific T lymphocytes via hepatic arterial infusion via central catheter over 60 minutes on day 0. Within 6 hours of T-cell infusion, patients also receive aldesleukin BID SC for 14 days in the absence of disease progression or unacceptable toxicity. POST T-CELL INFUSION: Patients receive ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aldesleukin

2012

Completed Phase 4

~1610

Ipilimumab

2015

Completed Phase 3

~3420