Status:
WITHDRAWN
Study of Busulfan for Refractory Central Nervous System (CNS) Tumors
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Refractory Brain Tumors
Eligibility:
All Genders
3-21 years
Phase:
PHASE1
Brief Summary
This protocol is aimed at establishing a maximum tolerated dose (MTD) for submyeloablative doses of Busulfex ® with the hope that a tolerable, submyeloablative dose can be established to test efficacy...
Detailed Description
Pediatric brain tumors remain among the most common malignancies in childhood, second only to leukemia, representing 20% of all childhood cancers in the United States (1). Although significant strides...
Eligibility Criteria
Inclusion
- Age: Age \>2 year and ≤ 21 years Histologic Diagnosis Any histological proven (confirmed by institutional pathology report; pathology slides from outside referring outside institutions are not required.) recurrent or progressive CNS tumor. (optic pathway and brainstem gliomas allowed without histologic verification, but must have diagnostic imaging).
- Life Expectancy Patients must have a life expectancy of ≥ 2 months. Prior Therapy There is no limit to the number of prior therapies a patient has received
- Must be ≥ 3 weeks from myelosuppressive chemotherapy (6 weeks from nitrosoureas) and have demonstrated recovery (ANC ≥ 1000/uL) from their last course of chemotherapy
- ≥ 6 months following allogeneic stem cell transplantation
- ≥ 3 months following autologous stem cell transplantation
- ≥ 3 months from craniospinal radiation
- ≥ 4 weeks from focal radiation
- ≥ 7 days from any past biologic/immunotherapy
- ≥ 1 week from any hematopoietic growth factors Concomitant Medication
- Patients taking Itraconazole or Phenytoin will be excluded. Patients must be off of these medications for at least 3 days prior to entering this trial. If the patient is taking phenytoin for seizures at the time of study enrollment, it must be stopped at least 3 days prior to starting therapy and Clonazepam will be substituted during the Busulfex ® infusions and for 24 hours following the infusion.
- Patients on growth stimulating factors, such as GCSF, will be allowed to continue these medications only as indicated in the study.
- Patients may be taking steroids while participating in this trial, but should be on a stable dose for \>1 week prior to enrollment.
- Medications interacting with the CYP3A4 substrate should also be avoided while the patient is on study.
- Patients should also be on Pneumocystis prophylaxis while participating in this study. Pentamidine will be required, with a recommended dose of 4 mg/kg given intravenously every month. Pentamidine should continue throughout the duration of the trial.
- Organ Function Requirements Adequate Bone Marrow Function Defined As
- Peripheral absolute neutrophil count (ANC) greater than or equal to 1000/ul (off growth factors x 48 hrs)
- Platelet count greater than or equal to 100,000/uL (transfusion independent)
- Hemoglobin greater than or equal to 8.0 gm/dL (may receive RBC transfusions) Adequate Renal Function Defined As
- Serum creatinine less than or equal to 1.5 x upper limit of normal, or
- Estimated creatinine clearance GFR greater than or equal to 70 ml/min/1.73 m² by the Schwartz formula Adequate Liver Function Defined As
- Total bilirubin within normal range
- SGPT (ALT) within normal range Adequate Pulmonary Function Defined As
- Oxygen saturation \>92% on room air Central Nervous System Function Defined As
- Patients with seizure disorder may be enrolled; Patients MUST be on an anti-seizure medication upon enrollment, but this medication CANNOT be phenytoin or carbamezepine.
- Patients must not be in status, coma or assisted ventilation prior to study enrollment.
- Stable neurologic exam of at least 1 week duration Performance Level Karnofsky/ Lansky 50 or greater
Exclusion
- Pregnancy/Contraception: patients who are pregnant or breast-feeding will not be eligible.
- Patients of childbearing potential must practice an effective method of birth control while participating on the study.
- Females \> 13 years of age or those who have achieved menarche must have a negative pregnancy test prior to study entry.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00836628
Start Date
July 1 2008
End Date
October 1 2010
Last Update
August 5 2020
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