Motexafin Gadolinium and Radiotherapy for Childhood Pontine Glioma
This study aims to determine the maximum tolerated dose of Motexafin Gadolinium when combined with radiotherapy in children with pontine glioma, ensuring that fewer than one-third of patients experience dose-limiting toxicity.
motexafin gadolinium
+ radiation therapy
+ pharmacological study
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma. II. Determine the toxic effects of this drug given at the MTD in these patients. III. Determine the intratumor and brain distribution of this drug by magnetic resonance imaging (MRI) in these patients. OUTLINE: This is a dose-escalation study of motexafin gadolinium. Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks. Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the MTD is determined. The first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for up to 3 years. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: Clinically and radiographically (MRI) proven newly diagnosed diffuse intrinsic brainstem glioma Greater than 50% intra-axial involvement of the pons, pons and medulla, pons and midbrain, or entire brainstem Contiguous involvement of the thalamus or upper cervical cord allowed Performance status - ECOG 0-2 More than 2 months Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL (transfusion allowed) No glucose 6 phosphate dehydrogenase deficiency Bilirubin no greater than 1.5 times normal SGOT or SGPT less than 1.5 times normal Creatinine no greater than 1.5 times normal Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent immunomodulating agents No other concurrent chemotherapy Concurrent corticosteroid therapy allowed for increased intracranial pressure only No prior cranial radiotherapy No prior motexafin gadolinium No other concurrent experimental agents
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location