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Immunotoxin Therapy in Treating Children With Recurrent Malignant Gliomas



Immunotoxin Therapy in Treating Children With Recurrent Malignant Gliomas

For Condition: recurrent childhood brain tumor
Status: Not yet recruiting
Sponsor(s): Pediatric Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating children who have recurrent or progressive malignant glioma.
Details: OBJECTIVES: Phase I: - Determine the toxicity of intratumoral IL13-PE38QQR in pediatric patients with recurrent malignant gliomas. - Determine the maximum tolerated flow rate and maximum tolerated infusion concentration (MTiC) of this drug in these patients. - Determine the histological effect of this drug in these patients. - Determine the radiographic response rate of patients treated with this drug (Group B ). - Compare the toxicity of a second intratumoral dose of IL13-PE38QQR in pediatric patients with or without prior surgical resection of recurrent malignant gliomas. Phase II: - Compare survival after initial progression in these patients treated at the maximum flow rate and MTiC with this drug with or without prior resection. - Compare progression-free survival of patients treated with this drug with or without prior resection. - Determine the histological effect of this drug in these patients. - Determine the radiographic response rate after two doses of this drug in these patients (Group B). OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to the recurrence being treated (first vs second or higher). All patients undergo stereotaxic biopsy. - Patients undergo surgical placement of 1-2 intratumoral catheters on day 1. Patients receive intratumoral IL13-PE38QQR continuously on days 2-6. Catheters are removed on day 6. On day 29, patients are assigned to 1 of 2 groups according to tumor resectability. - Group A: Patients undergo tumor resection and placement of 2-4 peritumoral catheters on day 29. Patients receive intratumoral IL13-PE38QQR continuously on days 31-35. - Group B: Patients undergo a second stereotaxic biopsy and placement of 1-2 intratumoral catheters on day 29. Patients receive IL13-PE38QQR as in Group A on days 30-34. Cohorts of 3 patients receive IL13-PE38QQR at escalating flow rates and a fixed concentration until the maximum safe flow rate is determined. The maximum safe flow rate is defined as the rate prior to the one at which 2 of 3 or more patients experience dose-limiting toxicity. Following determination of the maximum safe flow rate, cohorts of 2-3 patients receive IL13-PE38QQR at escalating concentrations and a fixed flow rate until the maximum tolerated infusion concentration (MTiC) is determined. The MTiC is defined as the concentration prior to the one at which 2 of 3 or more patients experience dose-limiting toxicity. - Phase II: Patients receive IL13-PE38QQR as above at the MTiC. Patients are followed at weeks 18 and 26 and then every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 76-92 patients (21-37 for phase I, 55 for phase II) will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed grade 3 or 4 supratentorial malignant glioma by prior surgery or biopsy - Anaplastic astrocytoma - Glioblastoma multiforme - Malignant mixed oligoastrocytoma - Recurrent or progressive disease - Must have 1 solid primary lesion with maximum diameter between 1 and 5 cm - 1 additional satellite lesion less than 3 cm from primary tumor allowed - Satellite lesion may not be larger than primary tumor - Must have received external beam radiotherapy with tumor dose of at least 48 Gy - No tumor crossing the midline - No more than 2 foci of tumor - No subependymal or leptomeningeal tumor dissemination - No impending herniation, including midline shift greater than 1 cm - No spinal cord compression - No requirement for immediate palliative treatment PATIENT CHARACTERISTICS: Age - 3 to 21 Performance status - Karnofsky 60-100% (over 16 years of age) - Lansky 60-100 (16 years of age and under) Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Hemoglobin at least 9 g/dL* - Platelet count at least 100,000/mm^3* NOTE: *Transfusion independent Hepatic - PT and PTT no greater than upper limit of normal Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled seizures PRIOR CONCURRENT THERAPY: Biologic therapy - At least 8 weeks since prior hematopoietic stem cell transplantation Chemotherapy - No prior intracerebral chemotherapy for malignant glioma (except polifeprosan 20 with carmustine implant) - At least 6 months since prior polifeprosan 20 with carmustine implant - At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas) - At least 2 weeks since prior vincristine or noncytotoxic chemotherapy - No concurrent chemotherapy Endocrine therapy - Concurrent steroids allowed Radiotherapy - See Disease Characteristics - At least 8 weeks since prior radiotherapy - No prior focal radiotherapy for malignant glioma (e.g., single-fraction stereotaxic radiotherapy or brachytherapy) Surgery - See Disease Characteristics Other - Recovered from prior therapy - At least 4 weeks since prior investigational agents - No prior localized antitumor therapy for malignant glioma - No other concurrent investigational agents
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AnuradhaBanerjee,  Study Chair,  University of California, San Francisco


Additional Information:
Study ID Numbers:  CDR0000269073;  NCI-5930,NEOPHARM-IL13PEI-151,PBTC-011
Study Start Date: 
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053040

Other Recurrent Childhood Brain Tumor Studies:
1. Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors

2. Immunotoxin Therapy in Treating Children With Recurrent Malignant Gliomas

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