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Phase I/II Study of ZD6474 in Patients With Recurrent High-Grade or Progressive Low-Grade Gliomas
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
ZD6474 in Treating Patients With Recurrent or Progressive Gliomas
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II, Phase I | Treatment | Active | 18 and over | NCI-06-C-0063 NCI-P6680, NCT00293566 |
Special Category:
NCI Web site featured trial, NIH Clinical Center trial Objectives Phase I - Establish the maximum tolerated dose of ZD6474 in patients with recurrent high-grade gliomas or progressive low-grade gliomas taking enzyme-inducing anti-epileptic drugs (EIAEDs).
- Obtain preliminary information regarding the spectrum of toxicities of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Obtain preliminary information regarding potential anti-tumor activity of this drug in these patients.
Phase II - Establish data regarding the anti-tumor activity of this drug in patients with recurrent high-grade gliomas not taking EIAEDs.
- Obtain preliminary information regarding the spectrum of toxicities of this drug in patients with recurrent high-grade gliomas not taking EIAEDs.
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
- See Disease Characteristics
- Recovered from prior therapy
- At least 6 weeks since prior radiation therapy, or nitrosoureas
- At least 4 weeks since prior temozolomide, carboplatin, or other cytotoxic therapies
- At least 4 weeks since prior resection of recurrent or progressive tumor
- At least 3 weeks since prior procarbazine
- At least 2 weeks since prior vincristine, non-cytotoxic agents (e.g., interferon or tamoxifen), or investigational agents
- Prior coronary artery bypass or angioplasty allowed provided there is no significant coronary artery disease and no myocardial wall dysfunction by cardiac evaluation within the past 3 months
- No concurrent steroids OR on a stable dose of steroids for ≥ 5 days before study entry
- No concurrent standard anticancer chemotherapy, radiation therapy, immunotherapy, or vasoconstrictors for the treatment of migraines (e.g., ergotamine, zolmitriptan, sumatriptan)
- No other concurrent investigational agents
Patient Characteristics:
- Life expectancy > 8 weeks
- Karnofsky performance status 60-100%
- WBC ≥ 3,000/mm3
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- SGOT and bilirubin ≤ 2 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL and/or creatinine clearance ≥ 60 mL/min
- Potassium, calcium, and magnesium normal (electrolyte supplementation allowed)
- No history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in remission and off all therapy for that cancer for ≥ 1 year
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
- No blood donation during and for ≥ 3 months after completion of study treatment
- No significant active hepatic, renal, or psychiatric diseases
- No active infection requiring IV antibiotics
- No significant cardiac event, including symptomatic congestive heart failure or evidence of cardiac ischemia (i.e., angina), within the past 3 months
- No cardiac disease that, in the opinion of the investigator, increases risk of ventricular arrhythmia
- No prior myocardial infarction unless there is no significant coronary artery disease (i.e., negative stress test) and no myocardial wall dysfunction by cardiac evaluation within the past 3 months
- No clinically significant arrhythmia (e.g., multifocal premature ventricular contraction, bigeminy, trigeminy, ventricular tachycardia, bradycardia) that is symptomatic or requires treatment (e.g., drugs or automatic implantable defibrillator)
- No asymptomatic sustained ventricular tachycardia
- No history of QTc prolongation with other medication
- No congenital long QT syndrome
- QTc < 460 msec by ECG or measurable Bazett's correction
- LVEF ≥ 45% by MUGA or echocardiogram, especially for patients with previous anthracycline therapy (total dose > 450 mg/m2), significant cardiovascular disease, or chest irradiation
- No hypertension not controlled by medical therapy (i.e., systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm HG)
- No other active or serious cardiac disease
- No currently active gastrointestinal disease with diarrhea that may affect the ability of the patient to absorb study drug or tolerate the diarrhea
- No other severe or uncontrolled systemic disease that would preclude study participation
Expected Enrollment 94A total of 94 patients will be accrued for this study. Outcomes Primary Outcome(s)Maximum tolerated dose (Phase I) Toxicity and pharmacokinetics Antitumor activity
Outline This is a phase I, dose-escalation study followed by a phase II study. Patients are stratified according to current use of enzyme-inducing anti-epileptic drugs (EIAEDs) (yes vs no). Patients who are on EIAEDs are enrolled into the phase I portion of the study. Patients who are not on EIAEDs are enrolled into the phase II portion of the study. Patients enrolled in the phase II portion of the study are further stratified according to tumor type (glioblastoma multiforme vs anaplastic glioma).
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | Howard Fine, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | Trial Sites
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U.S.A. |
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Maryland |
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Bethesda |
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| | | | | | | | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office |
| | Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office | |
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Related Information Featured trial article Web site for additional information
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | A Phase I/II Trial of ZD6474 for Patients with Recurrent High-Grade and Progressive Low-Grade Gliomas | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2006-01-13 | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2009-06-30 (estimated) | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00293566 | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2006-01-04 | ![](https://webarchive.library.unt.edu/eot2008/20090515064835im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2008-10-24 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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