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TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma Clinical research trials and TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma clinical trial. Participants frequently get the best healthcare available for their TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma  TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
For Condition: Childhood Oligodendroglioma,recurrent childhood supratentorial primitive neuroectodermal tumors,high-grade childhood cerebral astrocytoma,recurrent childhood cerebral astrocytoma
Status: Not yet recruiting
Sponsor(s): Pediatric Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: The TP-38 immunotoxin can locate tumor cells and kill them without harming normal cells. Giving TP-38 immunotoxin directly into the tumor may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of giving TP-38 immunotoxin directly into the brain in treating young patients who have recurrent or progressivesupratentorial high-gradeglioma.
Details: OBJECTIVES: Primary - Determine the maximum safe volume rate and maximum tolerated infusion concentration of TGFa-PE38 immunotoxin (TP-38) in pediatric patients with recurrent or progressive supratentorial high-grade glioma. - Determine the toxic effects of this drug in these patients. - Determine the efficacy of this drug, in terms of post-infusion survival, in these patients. Secondary - Determine the prevalence of epidermal growth factor receptor (EGFR) expression and phosphorylation (activity) in patients treated with this drug. - Correlate EGFR expression with qualitative measures (e.g., histology, grade, and other tumor characteristics) and tumor response, survival, and progression-free survival in patients treated with this drug. - Determine the objective response rate in patients treated with this drug. - Determine the progression-free survival of patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients in the phase II portion of the study are stratified according to time of recurrence of high-grade glioma (first vs second or greater). - Patients undergo stereotactic biopsy or resection of the tumor followed by intratumoral catheter placement for treatment infusion. Within 12-48 hours after intratumoral catheter placement, patients receive TGFa-PE38 immunotoxin (TP-38) intratumorally through the catheters over 33 to 124 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating volumes followed by escalating concentrations of TP-38 until the maximum safe volume (MSV) and maximum tolerated infusion concentration (MTIC) are determined. The MSV and MTIC are defined as the volume and concentration preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive treatment as in phase I at the MSV and MTIC. Patients are followed at 30 days, every 3 months for 1 year, and then every 6 months for at least 2 years. PROJECTED ACCRUAL: A total of 3-75 patients (3-30 for phase I and 45 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 supratentorial malignant glioma - Recurrent or progressive disease - Not amenable to gross total resection - Tumor must have a single solid portion at least 1 cm and no greater than 5 cm in maximum diameter - No tumor crossing the midline - Tumor invading the corpus callosum but not in the contralateral hemisphere is allowed - No more than 1 focus of tumor - No tumors involving the brainstem or cerebellum - No tumor dissemination (i.e., subependymal or leptomeningeal) - Must have received prior external beam radiotherapy (tumor dose at least 45 Gy) and completed therapy at least 8 weeks before study entry - No impending herniation, including midline shift greater than 0.5 cm - No requirement for immediate palliative treatment PATIENT CHARACTERISTICS: Age - 3 to 21 Performance status - Karnofsky 60-100% (patients over 16 years of age) OR - Lansky 60-100% (patients age 16 and under) Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3* - Hemoglobin at least 9 g/dL* NOTE: *Transfusion independent Hepatic - ALT and AST less than 2.5 times upper limit of normal (ULN) - PT and PTT no greater than ULN Renal - Creatinine less than 1.5 times normal OR - Glomerular filtration rate greater than 70 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 30 days after study participation - No uncontrolled seizures - No active infection requiring treatment - No unexplained febrile illness - No known or suspected allergies to local anesthetics - No systemic disease or other condition that may be associated with unacceptable anesthetic/operative risk and/or that would preclude study completion - No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - At least 8 weeks since prior hematopoietic stem cell transplantation Chemotherapy - At least 6 months since prior polifeprosan 20 with carmustine implant (Gliadel® wafer) - At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas and 2 weeks for vincristine) - At least 2 weeks since prior non-cytotoxic chemotherapy - No other prior intracerebral chemotherapy - No concurrent chemotherapy Endocrine therapy - Concurrent steroids allowed Radiotherapy - Se Disease Characteristics - No prior focal radiotherapy (e.g., gamma knife radiosurgery, stereotactic radiosurgery, or brachytherapy) - No concurrent radiotherapy Surgery - Not specified Other - Recovered from prior therapy - At least 4 weeks since prior anticancer investigational agents - No prior localized antitumor therapy for malignant glioma - No other concurrent investigational agent - No other concurrent anticancer (including alternative anticancer medicines/treatment) agent or therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertKeating, , Children's National Medical Center
Additional Information:
Study ID Numbers: CDR0000344416; PBTC-013
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074334
Other Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumors Studies:
1. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
2. Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
3. Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
4. Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
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TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
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