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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
Must not have
Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as: Active infection, Current active hepatic or renal disease
Planned or concurrent systemic treatment or radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of special immune cells and a cancer drug to treat patients with advanced melanoma that has spread to the brain. The immune cells aim to kill the cancer, and the drug helps stop its growth. A new treatment has shown effectiveness against advanced melanoma and brain involvement.
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.
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.
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 belowSelect...
I am not a candidate for precise, high-dose radiation therapy.
Select...
I have at least one brain tumor larger than 10 mm that is growing.
Select...
My melanoma is confirmed and has spread to other parts of my body.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I am older than 18 years.
Select...
It has been over 4 weeks since my last cancer treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any severe illnesses like active infections or liver/kidney diseases.
Select...
I am scheduled for or currently receiving chemotherapy or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Extracranial response rate (Phase II)
Temozolomide
Overall Survival (OS) (Phase II)
+2 moreOther study objectives
Cerebrospinal fluid shunts procedure
Immune activation post infusion
Natural Killer Cells
+1 moreAwards & 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 (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
2013
Completed Phase 2
~180
Temozolomide
2010
Completed Phase 3
~1880
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Melanoma treatments often include immune cell therapies and alkylating agents. Immune cell therapies, such as the use of natural killer (NK) cells, enhance the body's immune response by recognizing and destroying cancer cells, thereby boosting anti-tumor immunity.
This is crucial for melanoma patients as it leverages the body's natural defenses to target and eliminate cancer cells. Alkylating agents like Temozolomide work by adding alkyl groups to DNA, which interferes with the DNA replication process, ultimately slowing or stopping the growth of cancer cells.
This dual approach of enhancing immune response and directly targeting cancer cell replication is vital for effectively managing melanoma, especially in advanced stages.
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Who is running the clinical trial?
Kari KendraLead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled
Kari L Kendra, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not a candidate for precise, high-dose radiation therapy.I have at least one brain tumor larger than 10 mm that is growing.My melanoma is confirmed and has spread to other parts of my body.Your bilirubin levels in the blood should be less than 1.5 times the normal limit, unless you have Gilbert's syndrome.I do not have any severe illnesses like active infections or liver/kidney diseases.I can take care of myself and am up and about more than half of the day.I am mentally capable and have no major obstacles that would prevent me from following the study's requirements.I am on a stable dose of steroids for brain swelling.I am older than 18 years.You have been diagnosed with leptomeningeal metastases using an MRI.You have been part of another treatment study in the last 30 days.I have been cancer-free for over 3 years, except for certain non-aggressive cancers.It has been over 4 weeks since my last cancer treatment.Your kidney function, as measured by creatinine levels, is within a certain range.Your liver enzymes (AST and ALT) should be less than 5 times the normal limit if you have liver metastases, or less than 3 times the normal limit if you don't have liver metastases.I am scheduled for or currently receiving chemotherapy or radiation.I agree to use effective birth control during and after the treatment.I am a man who can father children and will use birth control or abstain from sex during the study.Women who could become pregnant must have a negative pregnancy test before starting the study treatment.Your platelet count is higher than 100,000 per microliter of blood.I am on the lowest dose of steroids needed for my brain metastasis symptoms.Your hemoglobin level is at least 10 grams per deciliter.Your absolute neutrophil count is 1 x 10^9/L or higher.Your albumin levels are at least 2.5 grams per deciliter.You have a medical reason that makes it unsafe for you to have an MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (UD TGFbetai NK cells, temozolomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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