Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095771
• Other study ID #: CDR0000393829
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2004
• Last updated: April 21, 2011
• Start date: November 2004
• Est. completion date: January 2011

Study information

• Verified date: April 2011
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• arsenic trioxide

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose as assessed by NCI CTCAE v. 3.0 following study completion			Yes
Primary	Safety as assessed by NCI CTCAE v. 3.0 following study completion			Yes