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Chemotherapy
NK Cells + Chemotherapy for Sarcoma (TINKS Trial)
Phase 1 & 2
Recruiting
Led By Bhuvana Setty, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-5 years
Awards & highlights
TINKS Trial Summary
This trial will study if adding NK cells to chemo can improve outcomes in kids w/ sarcomas that haven't responded to prior treatments.
Who is the study for?
This trial is for young people aged 12-40 with relapsed or refractory pediatric bone and soft tissue sarcomas, who've had limited prior treatments. They must have a certain level of physical ability, adequate organ function, controlled seizures if present, no severe allergies to specific drugs used in the study, and agree to use contraception.Check my eligibility
What is being tested?
The study tests whether adding TGFβ imprinted NK cells (a type of immune cell) to standard chemotherapy (gemcitabine and docetaxel) improves outcomes for these sarcoma patients. The treatment involves multiple cycles of chemo plus NK cell infusions over several weeks.See study design
What are the potential side effects?
Potential side effects include reactions from the infusion of NK cells or chemotherapy such as fatigue, nausea, infection risk increase due to lowered white blood cell counts, possible allergic reactions, and other common chemo-related issues like hair loss.
TINKS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1
Part 2
Secondary outcome measures
Frequency and characterization of DLT in study patients
Treatment response of target lesions determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Other outcome measures
Exploratory Endpoint
TINKS Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Part 1: Enrollment of 5 patients in each cohort (osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, and non-rhabdomyosarcoma).
Part 2: Enrollment of 2 cohorts in 2 stages for a total of 40 patients.
Find a Location
Who is running the clinical trial?
National Pediatric Cancer FoundationOTHER
4 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Sarcoma
122 Patients Enrolled for Sarcoma
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,456 Total Patients Enrolled
1 Trials studying Sarcoma
86 Patients Enrolled for Sarcoma
Bhuvana Setty, MDPrincipal InvestigatorNationwide Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had 1-4 treatments for sarcoma and surgery or radiation if needed.My tumor is close to vital body parts where swelling could cause major issues.My cancer is only in my bone marrow.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer has spread to my brain or spinal cord.I am allergic to docetaxel, gemcitabine, or peg-filgrastim.My nerve damage symptoms are mild to moderate.I (or my guardian) can understand and am willing to sign the consent form.I am HIV positive.I am mostly able to care for myself and do daily activities.My organs and bone marrow are functioning normally.I am not currently taking any cancer treatment medications.I am between 13 and 40 years old with a specific type of relapsed or hard-to-treat bone or soft tissue cancer.I have not received treatments like CAR-T cell therapy.I haven't had recent cancer treatments like chemotherapy, radiation, or specific drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the minimum age requirement for this research 18 years or older?
"This medical trial is enrolling individuals aged 12 and above, who are younger than 40 years old."
Answered by AI
Is this study currently enrolling participants?
"Affirmative, the details on clinicaltrials.gov reveal that this trial is currently seeking out participants. It was first posted on November 14th 2022 and its most recent update happened on May 2nd 2023. A total of 50 patients need to be enrolled from two sites in order for the study to progress."
Answered by AI
Are there any qualifications necessary to join this research trial?
"This sarcoma trial is currently recruiting 50 qualified individuals aged 12 to 40. In order to join, participants must not have taken diazepam nor any other chemotherapeutic agents in the past. Candidates with seizure disorders may still be eligible if their seizures can be properly managed without diazepam due to its possible adverse effects on NK cell activity."
Answered by AI
What is the total number of participants for this experiment?
"Affirmative. According to clinicaltrials.gov, this trial opened for applications on November 14th 2022 and was recently updated on May 2nd 2023. The study is seeking a total of 50 participants from two medical sites."
Answered by AI
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