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A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood


Phase 1
3 Years
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood


OBJECTIVES:

- Determine the maximum tolerated dose of arsenic trioxide when administered with
radiotherapy in pediatric patients with newly diagnosed anaplastic astrocytoma,
glioblastoma multiforme, gliosarcoma, or intrinsic pontine glioma.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of arsenic trioxide (ATO).

Patients undergo radiotherapy once daily, 5 days a week, for approximately 6 weeks. Patients
concurrently receive ATO IV over 1 hour, 1-5 times weekly, for approximately 6 weeks in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ATO until the maximum tolerated dose
(MTD) is determined. 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 2 months.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 3-36
months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Kenneth J. Cohen, MD, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000393829

NCT ID:

NCT00095771

Start Date:

November 2004

Completion Date:

January 2011

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood brain stem glioma
  • childhood high-grade cerebral astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410