Enzastaurin in Treating Young Patients With Refractory Primary CNS Tumors

Completed · Phase 1

Conditions studied: Brain and Central Nervous System Tumors, Neuroblastoma

In brief

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.

Key facts

Study ID

NCT00503724

Run by

Pediatric Brain Tumor Consortium

People needed

32

Starts

2007-06-01

Expected to finish

2010-05-01

Last updated by the study team

2012-03-06

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Medical Center at Parnassus — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Memorial Hospital - Chicago — Chicago, Illinois, United States
• Duke Comprehensive Cancer Center — Durham, North Carolina, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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