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CAR T-cell Therapy

Adoptive T Cell Therapy for Melanoma

Phase 1

Recruiting

Led By Michael Nishimura, PhD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

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

Must have

Patients must have a diagnosis of metastatic melanoma which is evaluable either clinically or radiologically.

Patients must be 18 years of age or older.

Must not have

Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior three months that was not controlled with surgery or radiotherapy.

Patients that have undergone immunotherapy targeting tyrosinase.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is to see if a new cancer therapy is effective and to what degree. The therapy uses the patient's own cells that are modified with a new gene.

Who is the study for?

Adults with advanced melanoma that can be measured, who are in good physical condition (ECOG PS of 0 or 1), and have tried certain treatments without success. They must not be pregnant, vulnerable individuals, or have severe infections or other health conditions that could interfere with the trial.

What is being tested?

This Phase I trial is testing escalating doses of genetically modified T cells to treat advanced melanoma. It's funded by the NCI and aims to find the right dose for Phase II trials. Participants receive a retrovirus-modified version of their own T cells.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, and flu-like symptoms; possible organ inflammation; and complications from cell infusion.

Eligibility Criteria

Inclusion Criteria

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

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My melanoma has spread and can be measured by tests or seen on scans.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I had anti-CTLA-4 treatment over 6 weeks ago and my cancer has since gotten worse.

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My melanoma is positive for tyrosinase and HLA-A2.

Exclusion Criteria

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

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I have not had active brain melanoma or treatment for it in the last 3 months.

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I have received immunotherapy targeting tyrosinase.

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I do not have any severe illnesses like uncontrolled high blood pressure or heart disease.

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I am on steroids for managing my disease or pain.

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I do not have any ongoing infections needing antibiotics.

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I need assistance with my daily activities.

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I have received immunotherapy along with mild chemotherapy.

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I have been diagnosed with HIV, HBV, or HCV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Approximately 18 patients with Grade 2 through Grade 5 Adverse Events that are related to study drug, graded according to NCI CTCAE Version 4.0

Secondary study objectives

Audiologic changes of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0

Physical Examination

Immunologic changes in T cell count

+1 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: Escalating DosesExperimental Treatment1 Intervention

Three patients will be treated at the first \& each subsequent dose level. Patients will be observed for 30 days post T cell infusion. If there was one DLT in the first 3 patients, an additional 3 patients will be treated at that level. If no additional DLTs are observed (for a total of 1 DLT in 6 patients) then the dose will be escalated. If two patients in the first 3 patients at a dose level experience a DLT, the dose will be de-escalated to the previous level \& an additional 3 patients will be enrolled at that level if 6 have not yet been treated at that level. The maximum tolerated dose (MTD) is defined as the highest dose at which 0 or 1 patient in six has experienced a DLT. If 2 or 3 patients in the first 3 patients experience a DLT at the first dose level, the study will terminate.

0 / 13Eligibility criteria met