Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma
This trial is active, not recruiting.
|Condition||brain and central nervous system tumors|
|Start date||July 2002|
|Trial identifier||NCT00052624, CDR0000258574, KSB-311P/CI/001, MUSC-10550|
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic astrocytoma.
PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Male or female participants from 5 years up to 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed glioblastoma multiforme or anaplastic astrocytoma with the following tumor characteristics: - Unifocal - Unilateral and supratentorial - Diameter no greater than 3.5 cm by contrast-enhanced MRI - No more than 1 satellite tumor - Recurrent or progressive disease - Progressive disease defined as at least 25% increase in tumor volume by serial MRI or CT scans and/or at least 15% increase in the largest cross-sectional area of tumor as defined by the area of contrast agent enhancement - Must have received prior conventional treatment comprising both of the following: - Surgery (biopsy or debulking) - Radiation therapy - No evidence of mass effect on CT scan or MRI with more than a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness, or clinically significant papilledema PATIENT CHARACTERISTICS: Age - 5 to 18 Performance status - Karnofsky 60-100% OR - Lansky Play 50-100% Life expectancy - At least 3 months Hematopoietic - Platelet count at least 100,000/mm^3 - Absolute neutrophil count at least 1,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL - AST and ALT no greater than 2.5 times the upper limit of normal (ULN) - PT or aPTT no greater than 1.5 times ULN Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 2 months after study - No acute viral, bacterial, or fungal infection requiring therapy - Topical treatment for oral candidiasis allowed - No other concurrent medical condition that would preclude anesthesia PRIOR CONCURRENT THERAPY: Biologic therapy - No prior transferrin-CRM107 Chemotherapy - More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - More than 3 months since prior biodegradable polymer wafers - No concurrent chemotherapy Endocrine therapy - Must be on stable dose of steroids for 7 days prior to infusion Radiotherapy - See Disease Characteristics - More than 3 months since prior radiotherapy - More than 3 months since prior stereotactic radiosurgery - More than 6 weeks since prior craniospinal irradiation - No prior brachytherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - More than 1 month since prior surgery including tumor surgery or debulking - No other concurrent surgery Other - More than 30 days since prior investigational agents - No other concurrent investigational therapy - No other concurrent anti-cancer drugs
|Official title||A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma|
|Description||OBJECTIVES: - Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric patients with progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma. - Determine the safety of this drug in these patients. - Determine the efficacy of this drug in these patients. - Compare the efficacy of this drug in patients with different histological types of tumor, degrees of transferrin receptor expression, and serum antidiphtheria antibody titer levels. OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups by age (5-9 vs 10-18). All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2 intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 (Tf-CRM107). - Group 1 (ages 5-9): Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter. Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity. Three cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum tolerated dose (MTD) is determined. - Group 2 (ages 10-18): Patients receive intratumoral Tf-CRM107 as in group 1. Two cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is determined. The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 6 months and then every 3 months for 6 months. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.|
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