|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00720564 |
|
Date of registration:
|
19/07/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma
|
|
Scientific title:
|
A Phase I Study of the Combination of Radiation Therapy (RT), Arsenic Trioxide (ATO) and Temozolomide (TMZ) in Patients With Newly-Diagnosed Glioblastoma Multiforme (GBM) |
|
Date of first enrolment:
|
April 2008 |
|
Target sample size:
|
18 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00720564 |
|
Study type:
|
Interventional |
|
Study design:
|
Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Jana Portnow, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Beckman Research Institute |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Brain and Central Nervous System Tumors
|
|
Intervention(s)
|
|
Drug: arsenic trioxide
|
|
Drug: temozolomide
|
|
Procedure: adjuvant therapy
|
|
Radiation: intensity-modulated radiation therapy
|
|
Radiation: radiation therapy
|
|
Primary Outcome(s)
|
|
Dose-limiting toxicities as measured by CTCAE version 3.0
[Time Frame: Yes]
|
|
Maximum tolerated dose of arsenic trioxide
[Time Frame: Yes]
|
|
Secondary ID(s)
|
|
CDR0000600335
|
|
CEPHALON-CHNMC-07058
|
|
CHNMC-07058
|
|
P30CA033572
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|