Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
Phase I Study of Combined Radiotherapy and Arsenic Trioxide for the Treatment of Newly Diagnosed Malignant Glioma
4 other identifiers
interventional
30
1 country
1
Brief Summary
This phase I trial is studying the side effects and best dose of arsenic trioxide and radiation therapy in treating patients with newly diagnosed malignant glioma. Drugs such as arsenic trioxide may stop the growth of malignant glioma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining arsenic trioxide with radiation therapy may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2002
CompletedStudy Start
First participant enrolled
October 1, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedApril 9, 2013
April 1, 2013
6.1 years
September 6, 2002
April 8, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose of ATO in conjunction with radiotherapy and optimum ATO dose for radiosensitization determined by dose-limiting toxicities
Results of the safety evaluation will be tabulated and displayed by dose level.
6 weeks
Proportion of patients with serious or life-threatening toxicities using the grading scale of Adverse Events Criteria
Results of the safety evaluation will be tabulated and displayed by dose level. The will be estimated along with 95% confidence intervals.
Up to 6 years
Secondary Outcomes (2)
Duration of survival with this treatment regimen
Up to 6 years
Overall event rates (hazards rates)
Up to 6 years
Study Arms (2)
Group A
EXPERIMENTALPatients receive arsenic trioxide IV over 2 hours once weekly for 6 weeks. Patients in both groups also undergo radiotherapy once daily 5 days a week for 6 weeks.
Group B
EXPERIMENTALPatients receive arsenic trioxide at a lower dose IV over 2 hours twice weekly for 6 weeks. Patients in both groups also undergo radiotherapy once daily 5 days a week for 6 weeks.
Interventions
Given IV
Undergo radiation therapy
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
- Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment
- Absolute neutrophil count 1500/mm\^3
- Platelets 100,000/mm\^3
- Creatinine =\< 1.5 mg/dL
- Total bilirubin \< 2 mg/dl
- Transaminases \< 4 times above the upper limits of the institutional normal
- Serum potassium \> 3.0 and \< 5.5mEq/l
- Magnesium \> 1.2 and \< 2.5 mEq/l
- Patients must give informed consent and understand the investigational nature of this study and its potential risks and benefits
- Patients must not be pregnant or breast-feeding; all patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception; patients who are pregnant or breast-feeding will be excluded because no information on this agent exists with regard to safety for a fetus or breast-feeding infant
- Patients must have a Karnofsky performance status of \>= 60%
- No other serious concurrent infection or other medical illness should be present which would jeopardize the ability of the patient to receive the therapy outlined in this protocol with reasonable safety
- Patients must have a mini mental score \>= 15
You may not qualify if:
- Patients with a prior malignancy; patients with curatively treated carcinoma in situ or basal cell carcinoma of the skin or patients who have been free of disease for \>= five years are eligible for this study
- Patients who are pregnant or breast-feeding; these patients are excluded because no information on this agent exists with regard to safety for a fetus or breast-feeding infant
- Prior therapy (surgery excluded) for the brain tumor
- Patients with second-degree heart block
- Patients who are being treated with Amphotericin B
- Patients who cannot undergo MRI are not eligible for this study
- Patients who are currently taking drugs that are known to prolong the QT interval; in order to be eligible patients will need to be off these drugs for \>= 5 days prior to starting treatment; patients may not resume these drugs for \> 2 weeks after last ATO treatment; if QT prolongation continues after 5 days post drug discontinuation, the patient is not eligible for ATO treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Approaches to Brain Tumor Therapy Consortium
Baltimore, Maryland, 21231-1000, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Ryu
New Approaches to Brain Tumor Therapy Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2002
First Posted
January 27, 2003
Study Start
October 1, 2002
Primary Completion
November 1, 2008
Last Updated
April 9, 2013
Record last verified: 2013-04