Is NCT04510051 recruiting in Ann Arbor, MI?

Yes, NCT04510051 is currently recruiting participants at its Ann Arbor, MI location. This malignant brain neoplasm clinical trial is actively enrolling qualified participants.

How do I join the malignant brain neoplasm clinical trial in Ann Arbor?

To join this clinical trial in Ann Arbor, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Ann Arbor clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Malignant Brain Neoplasm Clinical Trial in Ann Arbor, MI

About This Malignant Brain Neoplasm Study in Ann Arbor

This phase I trial investigates the side effects of chemotherapy and cellular immunotherapy in treating children with IL13Ralpha2 positive brain tumors that have come back after a period of improvement (recurrent) or do not respond to treatment (refractory). Cellular immunotherapy (IL13(EQ)BBzeta/CD19t+ T cells) are brain-tumor specific cells that may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many patients with brain tumor respond to treatment, but then the tumor starts to grow again. Giving chemotherapy in combination with cellular immunotherapy may kill more tumor cells and improve the outcome of treatment.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative.

Assent, when appropriate, will be obtained per institutional guidelines

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

Karnofsky Performance Status (KPS) \>= 60% except for loss of mobility due to disease involvement; e.g., confinement to a wheelchair due to spinal cord compression

Life expectancy \> 4 weeks

Participant has a prior histologically-confirmed malignant brain neoplasm and has progressed after prior conventional therapy

Radiographic evidence of progression/recurrence of the measurable disease more than 12 weeks after the end of the initial conventional therapy (including initial radiation therapy)

City of Hope (COH) clinical pathology confirms IL13Ralpha2+ tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score \>= 50)

If the participant has a shunt, it must be programmable and the participant must be able to tolerate the shunt being switched off for at least 2 consecutive days

Platelets \>= 50,000/mm\^3 (performed within 6 weeks of signing the main informed consent)

Total bilirubin =\< 2 X upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 6 weeks of signing the main informed consent)

Aspartate transaminase (AST) =\< 2 x ULN (performed within 6 weeks of signing the main informed consent)

Alanine transferase (ALT) =\< 2 x ULN (performed within 6 weeks of signing the main informed consent)

Creatinine clearance of \>= 75mL/min/1.73m\^2 (performed within 6 weeks of signing the main informed consent)

Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV)\

and active HBV (surface antigen negative) (performed within 6 weeks of signing the main informed consent)

If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed

Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 6 weeks of signing the main informed consent)

Agreement by females and males of childbearing potential\

to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.

Childbearing potential defined as not being surgically sterilized (males and females) or have not been free, once initiated, from menses for \> 1 year (females only)

ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR COLLECTION (PBMC) COLLECTION

Research participant must not require more than 0.1mg/kg/day total dose (0.03mg/kg/dose three times per day, max of 6mg/day) of Dexamethasone on the day of peripheral blood mononuclear cell (PBMC) collection

Research participant must have appropriate venous access

At least 2 weeks must have elapsed since the research participant received his/her last dose of prior targeted agents, chemotherapy or radiation

Note: If a research participant weighs less than 50kgs, the study team should provide the Donor Apheresis Center (DAC) with the participant's current weight so that institutional guidelines can be followed

ELIGIBILITY TO PROCEED WITH INDWELLING CENTRAL NERVOUS SYSTEM (CNS) CATHETER PLACEMENT

Serum creatinine \< 1.6 mg/dL

White blood cell (WBC) \>= 2,000/dL

Absolute neutrophil count (ANC) \>= 1,000

Platelets \> 50,000/dL

International normalized ratio =\< 1.3

Bilirubin \< 1.5 mg/dL

Alanine transferase (ALT) and aspartate transaminase (AST) \< 2 x upper limits of normal

KPS \>= 60% except for loss of mobility due to disease involvement; e.g., confinement to a wheelchair due to spinal cord compression

Second-line radiation therapy (post-leukapheresis) completed at least 4 weeks prior to surgical resection or biopsy/catheter placement

ELIGIBILITY TO PROCEED WITH LYMPHODEPLETION

Pulmonary: Research participant does not require supplemental oxygen to keep saturation greater than 95% and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive

Cardiac: Research participant does not require pressor support and/or does not have symptomatic cardiac arrhythmias

Active infection: Research participant does not have a fever exceeding 38.5 degree celsius; there is an absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to CAR T cell infusion and/or there aren't any indications of meningitis

Hepatic: Research participant serum total bilirubin or transaminases does not exceed 2 x normal limit

Renal: Research participant serum creatinine \< 1.8 mg/dL

Neurologic: Research participant does not have uncontrolled seizure activity following surgery prior to starting lymphodepletion

ELIGIBILITY TO PROCEED WITH EACH CAR T CELL INFUSION

Research participant has a released cryopreserved T cell product

Research participant does not require supplemental oxygen to keep saturation greater than 95% and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive

Research participant does not require pressor support and/or does not have symptomatic cardiac arrhythmias

Research participant does not have a fever exceeding 38.5 degree celsius; there is an absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to T cell infusion and/or there aren't any indications of meningitis

Research participant serum total bilirubin or transaminases does not exceed 2 x normal limit

Research participant serum creatinine \< 1.8 mg/dL

Research participant does not have uncontrolled seizure activity

Research participant platelet count must be \>= 50,000. However, if platelet level is between 25,000-49,000, then T-cell infusion may proceed after platelet transfusion is given and the post transfusion platelet count is \>= 50,000

Research participants must not require more than 0.1mg/kg/day total dose (0.03mg/kg/dose three times per day, max of 6mg/day) of dexamethasone during CAR T cell therapy

Wash-out requirements:

At least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen;

At least 23 days since the completion of temozolomide and/or 4 weeks for any other non-nitrosourea-containing cytotoxic chemotherapy regimen. If a patient's most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose

For bevacizumab the wash out period of at least 4 weeks is required before starting study treatment

Exclusion Criteria

Pulmonary: Research participant requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks

Cardiac: Research participant requires pressor support and/or has symptomatic cardiac arrhythmias

Renal: Research participant requires dialysis

Neurologic: Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy

Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study. A legal guardian may substitute for the research participant

Research participant with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the study team deems it unwise to enter the research participant on protocol shall be ineligible

Research participant with any other active malignancies

Research participant being treated for severe infection or recovering from major surgery is ineligible until recovery is deemed complete by the study team

Research participant with any uncontrolled illness including ongoing or active infection. Research participant with known active hepatitis B or C infection; research participant with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections

Research participant who has confirmed HIV positivity within 4 weeks of enrollment

Females only: Pregnant or breastfeeding

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT04510051) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Malignant Brain Neoplasm Treatment Options in Ann Arbor, MI

If you're searching for malignant brain neoplasm treatment options in Ann Arbor, MI, this clinical trial (NCT04510051) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this clinical trial. You'll receive care from experienced malignant brain neoplasm specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all malignant brain neoplasm clinical trials near you to find additional studies recruiting in your area.

Malignant Brain Neoplasm Clinical Trial in Ann Arbor, MI

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