NCT00095771

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with glioma. Drugs such as arsenic trioxide may also make the tumor cells more sensitive to radiation therapy. Combining arsenic trioxide with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining arsenic trioxide with radiation therapy in treating patients who have newly diagnosed gliomas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 22, 2011

Status Verified

April 1, 2011

Enrollment Period

6.2 years

First QC Date

November 9, 2004

Last Update Submit

April 21, 2011

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood brain stem gliomachildhood high-grade cerebral astrocytoma

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose as assessed by NCI CTCAE v. 3.0 following study completion

  • Safety as assessed by NCI CTCAE v. 3.0 following study completion

Interventions

arsenic trioxideDRUG
radiation therapyRADIATION

Eligibility Criteria

Age3 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Clinical and neuroradiographic findings consistent with intrinsic pontine glioma * Histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma * Multifocal high-grade gliomas allowed * No exophytic tumors * No focal lesions * No underlying diagnosis of neurofibromatosis * No tumors originating in anatomic structures adjacent to the cerebellar peduncle or cervical medullary junction PATIENT CHARACTERISTICS: Age * 3 to 21 Performance status * Karnofsky 60-100% OR * Lansky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Hemoglobin \> 10 g/dL * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin \< 2.0 mg/dL * Alkaline phosphatase \< 2.5 times upper limit of normal (ULN) * Transaminases \< 2.5 times ULN Renal * Creatinine \< 2.0 times ULN Cardiovascular * No second-degree heart block * No absolute QTc interval \> 500 msec with normal potassium and magnesium levels Other * Not pregnant or nursing * Negative pregnancy test * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ * No other serious medical illness * Able to undergo MRI PRIOR CONCURRENT THERAPY: Biologic therapy * More than 28 days since prior biologic therapy * No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) Chemotherapy * No prior arsenic trioxide Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Prior surgery for the brain tumor allowed Other * No other prior therapy for the brain tumor * More than 28 days since prior investigational drugs or devices * No concurrent amphotericin B

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytoma

Interventions

Arsenic TrioxideRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen CompoundsTherapeutics

Study Officials

  • Kenneth J. Cohen, MD, MBA

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

November 1, 2004

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 22, 2011

Record last verified: 2011-04

Locations

US(1)