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Alkylating agents

Genetically Modified T Cells for Ovarian Cancer

Phase 1

Waitlist Available

Led By Roisin O'Cearbhaill, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Presence of measurable recurrence, with RECIST measurable disease at the time of intervention consent

Patients must have had one prior platinum-based chemotherapeutic regimen for management of ovarian, primary peritoneal, or fallopian tube carcinoma and at least two prior chemotherapy regimens

Must not have

Known or suspected leptomeningeal disease; patients with metastases to the brain stem, midbrain, pons or medulla

Any of the following cardiac conditions: Clinically significant heart disease (NYHA class III or IV) or symptomatic congestive heart failure, Myocardial infarction ≤6 months prior to enrollment, History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration, History of severe non-ischemic cardiomyopathy with ejection fraction ≤20%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of using specially prepared cells to treat ovarian cancer. The goal is to find a safe dose and to see what effects the cells have on the patient and their cancer.

Who is the study for?

This trial is for adults with high-grade serous ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred. They must have measurable disease, a life expectancy of over 3 months, and no recent cancer treatments. Their tumors should express MUC16ecto antigen and they've had at least one platinum-based chemotherapy. Exclusions include bowel obstruction, autoimmune diseases (except stable thyroid), brain metastases, seizure history, significant heart conditions, active infections like hepatitis B/C or HIV.

What is being tested?

The study tests the safety of different doses of modified T cells targeting the MUC16 protein on certain solid tumors. It involves collecting patients' T cells and genetically modifying them to attack tumor cells before being infused back into the patient's body along with pre-treatment drugs Cyclophosphamide and Fludarabine.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation in various organs due to targeted cell destruction by modified T cells; complications from infusion procedures; effects from pre-treatment drugs like nausea or low blood counts.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned and can be measured for its size.

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I have had one platinum-based and at least two other chemotherapy treatments for ovarian, peritoneal, or fallopian tube cancer.

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I am able to care for myself but cannot do normal activities or work.

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My cancer tests positive for the MUC16ecto antigen.

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I am 18 years old or older.

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

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I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.

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I haven't had cancer treatment in the last 3 weeks and no immunotherapy in the last 6 months.

Exclusion Criteria

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

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I have cancer that has spread to my brain or its coverings.

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I have serious heart conditions, including recent heart attack or severe heart failure.

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I have an active hepatitis B, or a history of hepatitis C or HIV.

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I do not have any other cancers needing treatment besides ovarian cancer.

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I have had radiation therapy to my abdomen or pelvis.

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I have or might have extensive scar tissue in my abdomen.

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I have signs of a blocked intestine or need IV fluids or feeding.

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I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

evidence of anti-tumor activity

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: Cyclophosphamide followed by Autologous T CellsExperimental Treatment5 Interventions

Cohorts of 3-6 pts will be infused with escalating doses of modified T cells to establish the MTD of modified T cells. There are 5 planned dose levels: 3 x 10\^5, 1 x 10\^6, 3 x 10\^6, \& 1 x 10\^7 \& 3 x 10\^7 4H11-28z/fIL-12/EGFRt+ T cells/kg. Cohort I-IV \& VI will be treated escalating dose levels. Once the MTD of T cells is established, the next cohort will receive lymphodepleting cyclophosphamide dose of 750 mg/m\^2 or a regimen of cyclophosphamide dose 300 mg/m2 x 3 days concurrent with fludarabine dose 25-30 mg/m2 x 3 days 2-7 days prior to starting the T cell infusion at one dose level below the MTD. If MTD isn't established after Cohort IV, Cohort V will receive conditioning chemotherapy 2-7 days prior to starting the T cell infusion at the same dose as Cohort III. Pts in Cohort V received cyclophosphamide chemotherapy on Day 1 or cyclophosphamide concurrent with fludarabine on Day 1-3, followed 2 to 4 days later by T cell infusion. This cohort is closed to further accrual.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1830