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New treatment option for Astrocytoma
Official title First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
ClinicalTrials.gov ID: NCT07560865
What this study is testing
What is FT536?
FT536 is an investigational medicine, being studied as a potential treatment for astrocytoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single center, first-in cancer-type phase I clinical trial of FT536 for adult patients with recurrent WHO Grade 4 astrocytoma, irrespective of IDH-mutational status, for which a standard of care repeat craniotomy for gross tumor resection at time of first or second recurrence is achievable. Per this treatment schema, FT536 will be administered once intratumorally
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically confirmed WHO Grade 4 astrocytoma from archival tissue. IDH mutation status and MGMT promoter methylation status will not limit...
- Evidence of first or second cancer recurrence/ progression by magnetic resonance imaging (MRI) for which a gross tumor resection (GTR) is feasible as...
- Previous completed SOC antitumor treatment including surgery, radiation therapy, and temozolomide +/- Optune/ Tumor Treatment Fields (TTF).
- No concurrent alternative curative therapy, including use of TTF.
- Able to undergo standard MRI scans with contrast agent throughout the course of the study.
You likely can't join if
- Clinically significant increased intracranial pressure (e.g., impending herniation or requirement for immediate palliative treatment) or uncontrolled...
- History of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/ AML.
- Radiographic evidence of leptomeningeal disease.
- Received prior treatment with bevacizumab or any other cellular therapy available on or off a clinical trial.
- Non-malignant CNS disease such as CNS vasculitis or neurodegenerative disease.
- Prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy.
See the full eligibility criteria
- Histologically confirmed WHO Grade 4 astrocytoma from archival tissue. IDH mutation status and MGMT promoter methylation status will not limit candidacy but needs to be known.
- Evidence of first or second cancer recurrence/ progression by magnetic resonance imaging (MRI) for which a gross tumor resection (GTR) is feasible as determined by the primary investigator in concordance with the...
- Previous completed SOC antitumor treatment including surgery, radiation therapy, and temozolomide +/- Optune/ Tumor Treatment Fields (TTF).
- No concurrent alternative curative therapy, including use of TTF.
- Able to undergo standard MRI scans with contrast agent throughout the course of the study.
- ≥ 18 years and ≤ 75 years of age at the time of consent.
- Karnofsky performance status ≥70.
- Must be completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function at the time of enrollment.
- Adequate organ function within 14 days of study treatment start as defined in Section 4.1.9 of the protocol.
- Participants of childbearing potential (POCBP) or with partners of childbearing potential must use a highly effective form of contraception from the time of the screening visit until at least 3 months after the dose of...
- Must agree to and sign the consent for the companion Long-Term Follow-Up study (CPRC# 2021LS077).
- Voluntary written consent prior to the performance of any research related procedures.
- Agree to stay in the Twin Cities metropolitan area (i.e. within a 45-minute drive of the UMN) from the time of biopsy through hospital discharge following completion of the planned craniotomy.
- Clinically significant increased intracranial pressure (e.g., impending herniation or requirement for immediate palliative treatment) or uncontrolled seizures or any other situation requiring urgent neurosurgical...
- History of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/ AML.
- Radiographic evidence of leptomeningeal disease.
- Received prior treatment with bevacizumab or any other cellular therapy available on or off a clinical trial.
- Non-malignant CNS disease such as CNS vasculitis or neurodegenerative disease.
- Prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy.
- Any known condition that requires systemic immunosuppressive therapy - inhaled and topical steroids are permitted.
- Pregnant or breastfeeding. Menstruating POCBP must have a negative pregnancy test within 14 days before the planned biopsy. Patient must agree to use highly effective method of birth control from the time of the...
- Known seropositive for HIV or known Hepatitis B or C infection with detectable viral load by PCR.
- Prior history of malignancy within 5 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with...
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pec
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.