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Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00045565
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE September 6, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date April 9, 2013
Study Start Date  ICMJE October 2002
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
  • Maximum tolerated dose of ATO in conjunction with radiotherapy and optimum ATO dose for radiosensitization determined by dose-limiting toxicities [ Time Frame: 6 weeks ]
    Results of the safety evaluation will be tabulated and displayed by dose level.
  • Proportion of patients with serious or life-threatening toxicities using the grading scale of Adverse Events Criteria [ Time Frame: Up to 6 years ]
    Results of the safety evaluation will be tabulated and displayed by dose level. The will be estimated along with 95% confidence intervals.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00045565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
  • Duration of survival with this treatment regimen [ Time Frame: Up to 6 years ]
    Non-parametric estimates of survival will be calculated.
  • Overall event rates (hazards rates) [ Time Frame: Up to 6 years ]
    Will be estimated with 95% confidence intervals.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
Official Title  ICMJE Phase I Study of Combined Radiotherapy and Arsenic Trioxide for the Treatment of Newly Diagnosed Malignant Glioma
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.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of Arsenic Trioxide (ATO) when administered on a once a week schedule and a twice a week schedule in conjunction with radiation therapy to patients with newly diagnosed glioblastoma multiforme.

II. To determine the toxicity of ATO when it is administered on a once a week schedule and a twice a week schedule in conjunction with radiation therapy in patients with newly diagnosed glioblastoma multiforme.

SECONDARY OBJECTIVES:

I. To determine the survival of patients with newly diagnosed glioblastoma multiforme receiving ATO when it is administered on a once a week schedule and a twice a week schedule in conjunction with radiation therapy.

II. To evaluate the effect of ATO on tumor vasculature by using perfusion MRI. III. To describe the pharmacokinetics of ATO following weekly and twice weekly injection.

OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of arsenic trioxide. Patients are assigned to 1 of 2 treatment groups.

Group A: Patients receive arsenic trioxide IV over 2 hours once weekly for 6 weeks.

Group B: Patients 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.

In both groups, cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.

Patients are followed weekly for 4 weeks and then every 2 months thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
Intervention  ICMJE
  • Drug: arsenic trioxide
    Given IV
    Other Names:
    • Arsenic (III) Oxide
    • Arsenic Sesquioxide
    • Arsenous Acid Anhydride
    • AS2O3
    • Trisenox
  • Radiation: radiation therapy
    Undergo radiation therapy
    Other Names:
    • irradiation
    • radiotherapy
    • therapy, radiation
Study Arms  ICMJE
  • Experimental: Group A
    Patients 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.
    Interventions:
    • Drug: arsenic trioxide
    • Radiation: radiation therapy
  • Experimental: Group B
    Patients 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:
    • Drug: arsenic trioxide
    • Radiation: radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2013)
30
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00045565
Other Study ID Numbers  ICMJE NCI-2012-03162
NABTT-2115
JHOC-NABTT-2115
U01CA062475 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Ryu New Approaches to Brain Tumor Therapy Consortium
PRS Account National Cancer Institute (NCI)
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP