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CAR T-cell Therapy

NK Cell Therapy + Temozolomide for Melanoma with Brain Metastasis

Phase 1 & 2
Recruiting
Led By Kari L Kendra, MD
Research Sponsored by Kari Kendra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No indication for stereotactic radiotherapy
Radiologically confirmed brain metastasis (n >= 1) with at least one measurable central nervous system (CNS) lesion >= 10 mm on T1-weighted gadolinium enhanced magnetic resonance imaging (MRI) and unequivocal evidence of progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial tests a possible new treatment for melanoma that has spread to the brain. NK cells attack cancer cells and temozolomide slows their growth, working together to shrink tumors.

Who is the study for?
This trial is for adults over 18 with stage IV melanoma that has spread to the brain. Participants must have finished any cancer treatments at least 4 weeks prior, have certain normal organ function tests, and no severe mental status changes or other serious medical conditions. Women of childbearing age and men who can father a child must use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of UD TGFbetai NK cell therapy combined with temozolomide in shrinking brain tumors caused by melanoma. It's exploring the best dose of these therapies in patients whose cancer has advanced despite previous treatments.See study design
What are the potential side effects?
Potential side effects may include reactions from the immune system due to NK cell therapy, as well as typical chemotherapy-related issues like fatigue, nausea, hair loss, and increased risk of infections from temozolomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not a candidate for precise, high-dose radiation therapy.
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I have at least one brain tumor larger than 10 mm that is growing.
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My melanoma is confirmed and has spread to other parts of my body.
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I can take care of myself and am up and about more than half of the day.
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I am older than 18 years.
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It has been over 4 weeks since my last cancer treatment.
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I agree to use effective birth control during and after the treatment.
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I am a man who can father children and will use birth control or abstain from sex during the study.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limited toxicities (Phase I)
Incidence of adverse events (AEs) (Phase I)
Proportion of subjects who achieve an intracranial complete response or partial response (Phase II)
Secondary outcome measures
Extracranial response rate (Phase II)
Natural Killer Cells
Temozolomide
+3 more
Other outcome measures
Cerebrospinal fluid shunts procedure
Immune activation post infusion
Natural Killer Cells
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (UD TGFbetai NK cells, temozolomide)Experimental Treatment2 Interventions
Patients receive UD TGFbetai NK cells IV over 30 minutes on day 1 and temozolomide PO daily on days 1-5. Treatment with UD TGFbetai NK cells repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Cycles of temozolomide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natural Killer Cell Therapy
2008
Completed Phase 2
~110
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Kari KendraLead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Melanoma
8 Patients Enrolled for Melanoma
Kari L Kendra, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Natural Killer Cell Therapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05588453 — Phase 1 & 2
Melanoma Research Study Groups: Treatment (UD TGFbetai NK cells, temozolomide)
Melanoma Clinical Trial 2023: Natural Killer Cell Therapy Highlights & Side Effects. Trial Name: NCT05588453 — Phase 1 & 2
Natural Killer Cell Therapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05588453 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the specified condition able to enroll in this experiment right now?

"The clinical trial in question is not presently looking for patients. This can be found on clinicaltrials.gov, which also states that the last edit to this posting was on 10/18/2022. Although this study is no longer enrolling, there are 3215 other trials that are currently recruiting participants."

Answered by AI
~12 spots leftby Dec 2024