Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma

NCT00720564 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000600335P30CA033572CHNMC-07058CEPHALON-CHNMC-07058
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide and temozolomide may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with temozolomide and radiation therapy in treating patients with newly diagnosed high-grade glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult gliosarcoma; adult mixed glioma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of arsenic trioxide

• Dose-limiting toxicities as measured by CTCAE version 3.0

Interventions

arsenic trioxide DRUG

temozolomide DRUG

adjuvant therapy PROCEDURE

intensity-modulated radiation therapy RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Newly diagnosed grade III or IV glioma including any of the following: * Glioblastoma * Anaplastic astrocytoma * Gliosarcoma * Anaplastic oligodendroglioma * Anaplastic oligoastrocytoma * Measurable or nonmeasurable disease * No more than 5 weeks since prior brain surgery * Recovered from surgery, post- operative infection, and other complications * Preoperatively and postoperatively diagnostic contrast-enhanced MRI or CT scan of the brain performed prior to radiation therapy * Patients diagnosed by stereotactic biopsy do not require the postoperative scan PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 60% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 2.0 mg/dL * AST ≤ 4.0 times ULN * No prolonged QT interval \> 460 milliseconds on baseline electrocardiogram in the presence of normal serum potassium and magnesium * No uncontrolled electrolyte imbalance (i.e., sodium \< 132 mmol/L, potassium \< 3.5 mEq/dL, magnesium \< 1.7 mg/dL) * No history of torsades de pointes type of ventricular arrhythmia * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective contraception * No medical or psychiatric illness that, in the investigator's opinion, could potentially preclude the completion of study therapy * No HIV positivity * No active connective tissue disorders (e.g., lupus or scleroderma) that, in the investigator's opinion, may put the patient at high risk for radiation toxicity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior brain radiotherapy or chemotherapy for brain tumor * Concurrent corticosteroids to control cerebral edema allowed provided dose is stable or decreasing for the past 5 days * No concurrent or plan to receive drugs that are known to prolong the QT interval * No prior radiation to the head or neck (except for T1 glottic cancer) resulting in overlap of radiation fields

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Astrocytoma; Oligodendroglioma; Gliosarcoma; Glioma

Interventions

Arsenic Trioxide; Temozolomide; Chemotherapy, Adjuvant; Radiotherapy, Intensity-Modulated; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Officials

• Jana Portnow, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2008
• First Posted: July 22, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

US (1)