Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00045565

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: arsenic trioxide Radiation: radiation therapy	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Study of Combined Radiotherapy and Arsenic Trioxide for the Treatment of Newly Diagnosed Malignant Glioma

Resource links provided by NLM:

MedlinePlus related topics: Arsenic Cancer

Drug Information available for: Arsenic trioxide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	October 2002
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the maximum tolerated dose of 2 different dosing schedules of arsenic trioxide in combination with radiotherapy in patients with newly diagnosed malignant glioma.
Determine the toxicity of these regimens in these patients.

Secondary

Determine the survival of patients treated with these regimens.
Evaluate the effect of arsenic trioxide on tumor vasculature in these patients.
Determine the pharmacokinetics of arsenic trioxide in these patients.

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.

PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study within 6-15 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin less than 2 mg/dL
AST/ALT less than 4 times upper limit of normal

Renal

Creatinine no greater than 1.5 mg/dL

Cardiovascular

No second-degree heart block

Other

Potassium greater than 3.0 mEq/L and less than 5.5 mEq/L
Magnesium greater than 1.2 mEq/L and less than 2.5 mEq/L
Mini mental score at least 15
Able to undergo MRI
No concurrent serious infection
No other medical illness that would preclude study participation
No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior immunotherapy or biologic therapy for this disease (e.g., immunotoxins, immunoconjugates, antisense therapy, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cell therapy, or gene therapy)

Chemotherapy

No prior chemotherapy for this disease

Endocrine therapy

No prior hormonal therapy for this disease
Prior glucocorticoid therapy allowed
Must be on a stable corticosteroid regimen (i.e., no increase for 5 days)

Radiotherapy

No prior radiotherapy for this disease

Surgery

Recovered from prior surgery
Prior surgery allowed

Other

At least 5 days since prior drugs that are known to prolong QT interval
- Patients who continue to experience QT prolongation 5 days after discontinuation of the drug are not eligible
No other prior therapy for this disease
No concurrent amphotericin B
No drugs that are known to prolong QT interval during or for 2 weeks after study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045565

Locations

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Samuel Ryu, MD

Josephine Ford Cancer Center at Henry Ford Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000256614, NABTT-2115, JHOC-NABTT-2115
Study First Received:	September 6, 2002
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00045565 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Arsenic trioxide
Central Nervous System Neoplasms
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009