Clinical trial · Interventional
Enzastaurin in Treating Young Patients With Refractory Primary CNS Tumors
Phase I and Pharmacokinetic Study of Enzastaurin (LY317615) in Children and Adolescents With Refractory Primary CNS Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin in treating young patients with refractory primary brain tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzastaurin hydrochloride | Drug | Enzastaurin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- First 28 days of therapy
- description
- The maximum tolerated dose or recommended phase II dose will be based on the dose-limiting toxicities observed during the first 28 days of therapy in those participants receiving enzastaurin on a once per day dosing schedule.
- measure
- Number of participants treated with the maximum tolerated dose or phase II recommended dose on a twice daily dosage schedule with dose-limiting toxicities
- timeFrame
- First 28 days of therapy
Secondary outcomes (6)
- measure
- Pharmacokinetics
- timeFrame
- Three days prior to course 1 and day 28 of course 1
- description
- Blood samples for pharmacokinetic studies will be drawn 3 days prior to course 1 and on day 28 of course 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary CNS malignancy including low-grade glioma
* All tumors, except intrinsic brain stem and diffuse optic pathway tumors, must have histological verification at either the time of diagnosis or recurrence
* Patients with intrinsic brain stem or diffuse optic pathway tumors must have clinical and/or radiographic evidence of progression
* Recurrent or progressive disease or disease refractory to standard therapy and for which there is no known curative therapy
PATIENT CHARACTERISTICS:
Inclusion Criteria:
* Karnofsky performance scale (for \> 16 years of age) or Lansky performance score (for ≤ 16 years of age) ≥ 60% assessed within two weeks prior to registration
* Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
* Platelet count ≥ 100,000/μL (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
* Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine based on age as follows:
* 0.8 mg/dL (≤ 5 years of age)
* 1.0 mg/dL (6 to 10 years of age)
* 1.2 mg/dL (11 to 15 years of age)
* 1.5 mg/dL (≥ 16 years of age)
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
* ALT ≤ 5 x ULN for age
* Serum albumin ≥ 2.5 g/dL
* Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
* Negative pregnancy test
* Patients must have a normal QTc for age and no evidence of a clinically significant arrhythmia on ECG
* No evidence of active graft-versus-host disease
Exclusion Criteria:
* Pregnant or lactating
* Body surface area \< 0.5 m\^2
* Clinically significant unrelated systemic illness that would compromise the patient's ability to tolerate protocol therapy or would likely interfere with the study procedures or results
* Known hypersensitivity to enzastaurin hydrochloride or its components
* Inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
PRIOR CONCURRENT THERAPY:
Inclusion Criteria:
* Must have recovered from the acute toxic effects (grade ≤ 2) of all prior therapy before entering this study
* Must not have received myelosuppressive chemotherapy within 3 weeks of entry onto this study (6 weeks for prior nitrosourea)
* At least 7 days since the completion of therapy with a hematopoietic growth agent (i.e., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or erythropoietin)
* At least 14 days since long-acting formulations
* Therapeutic use of myeloid growth factors in patients with serious neutropenic conditions, such as sepsis, may be considered at the investigator's discretion
* At least 7 days since the completion of therapy with a biologic agent
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months must have elapsed after prior total body irradiation (TBI) or craniospinal radiotherapy
* At least 6 weeks must have elapsed after other substantial bone marrow irradiation
* At least 6 months since prior allogeneic bone marrow transplantation
* At least 3 months since prior autologous bone marrow or stem cell transplantation
* Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration
* Corticosteroids should be used at the lowest dose to control symptoms of edema and mass effect
Exclusion Criteria:
* Routine concurrent use of growth factors (i.e., G-CSF, GM-CSF, or erythropoietin)
* Any other concurrent anticancer or investigational drug therapy
* Concurrent enzyme-inducing anticonvulsants (EIACDs)
* Concurrent gents that prolong the QTc
* Concurrent drugs that are substrates or inhibitors of CYP3A4 or CYP2C9
* Other concurrent drugs that are sensitive substrates of CYP2C8, CYP2C9, or CYP2C19 and/or have a narrow therapeutic windowReferences
Publications (0)
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