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New treatment option for Astrocytoma, IDH-Mutant, Grade 2
Official title Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma
ClinicalTrials.gov ID: NCT06860594
What this study is testing
What is Triapine?
Triapine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for astrocytoma, idh-mutant, grade 2.
Also referred to as 3-aminopyridine-2-carboxaldehyde thiosemicarbazone, 3-AP.
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 phase I trial tests the safety, side effects, and best dose of triapine in combination with radiation therapy in treating patients with glioblastoma or astrocytoma that has come back after a period of improvement (recurrent). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 1: an early, usually small safety study
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically, molecularly, or cytologically confirmed recurrent astrocytic tumors including:
- GBM or variants, IDH-wildtype, grade 2-4 (standard curative measures available or not)
- Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not)
- Diffuse midline gliomas, including pediatric-type H3 G34 or E3 K27 mutant tumors.
- Tumors ≤ 6 cm in maximal diameter.
You likely can't join if
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception...
- Patients who are receiving any other investigational agents.
- Patients who are actively taking medications that are known to induce methemoglobinemia (e.g. sulfonamides, nitrofurans, anti-malarials [primaquine...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine.
- Patients with known G6PD deficiency. Testing for G6PD deficiency is not required.
- Patients with uncontrolled intercurrent illness, active infections, or any other significant condition(s) that would make participation in this...
See the full eligibility criteria
- Patients must have histologically, molecularly, or cytologically confirmed recurrent astrocytic tumors including:
- GBM or variants, IDH-wildtype, grade 2-4 (standard curative measures available or not)
- Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not)
- Diffuse midline gliomas, including pediatric-type H3 G34 or E3 K27 mutant tumors.
- Tumors ≤ 6 cm in maximal diameter.
- Patients who had recent resection for recurrent tumor must have measurable disease.
- Patients must have at least a 6-month break from last dose of radiation therapy. Re-irradiation within 6 months may increase risk for radiation necrosis/edema, which will affect toxicity assessment and patient safety...
- Prior history of standard dose radiation for gliomas of 59.4-60 gray (Gy) in 1.8-2 Gy per fraction (or equivalent or lower) is allowed.
- Patients who received non-standard radiation dose regimen (e.g., 40 Gy, 34-35 Gy, 25 Gy) or stereotactic radiosurgery are eligible as long as there is at least one of the following:
- A new tumor outside the original radiotherapy field as determined by the investigator.
- There is histologic confirmation of tumor on biopsy or resection.
- Imaging findings are consistent with true progressive disease (on standard MRI sequences, MRI spectroscopy/perfusion, or nuclear medicine imaging).
- Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of triapine in patients \< 18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
- Absolute neutrophil count ≥ 1,500/mcL.
- Hemoglobin ≥ 8 g/dL.
- Platelets ≥ 100,000/mcL.
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional ULN.
- Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Patients must be able to swallow whole capsules.
- Patients must be able to undergo MRIs with contrast. Patients with non-compatible devices with MRI can be eligible if CT scans of sufficient quality are obtained. However, patients without non-compatible devices may not...
- The effects of triapine on the developing human fetus are unknown. For this reason and because ribonucleotide reductase (RNR) inhibitor agent and radiation are known to be teratogenic, women of child-bearing potential...
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- Patients who are actively taking medications that are known to induce methemoglobinemia (e.g. sulfonamides, nitrofurans, anti-malarials [primaquine, chloroquine], cyclophosphamide, and ifosfamide).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine.
- Patients with known G6PD deficiency. Testing for G6PD deficiency is not required.
- Patients with uncontrolled intercurrent illness, active infections, or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
- Pregnant women are excluded from this study because triapine is a RNR inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Orange, California, United States
- Sacramento, California, United States
- New Haven, Connecticut, United States
- Trumbull, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- North Miami, Florida, United States
- Plantation, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Shiloh, Illinois, United States
- Fairway, Kansas, United States
+ 17 more site(s).
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; Orange, California, United States; Sacramento, California, United States; New Haven, Connecticut, United States and 31 more location(s). 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.