Recurrent High-Grade GliomasPhase 1NCT00272350
ZD6474 to Treat Advanced Brain Cancer in Patients
A Phase 1 study testing Steroids and ZD6474 in people with Recurrent High-Grade Gliomas and Progressive Low-Grade Gliomas, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various preclinical tumor models. Given the pronounced neovasculature associated with malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent High-Grade Gliomas, Progressive Low-Grade Gliomas, Malignant Gliomas
- What is being tested?
- Steroids and ZD6474
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2005to 27 Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven malignant primary gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), and malignant glioma/astrocytoma NOS. Additionally, patients with progressive low-grade gliomas and patients with infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy.
- Patients must have an MRI scan performed within 14 days prior to registration.
- Patients having undergone recent resection of a recurrent or progressive tumor, will be eligible four weeks after surgery.
- Patients must have failed prior radiation therapy.
- All patients or their PREVIOUSLY DESIGNATED DPA (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired is such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients must be greater than or equal to 18 years old, and must have a life expectancy greater than 8 weeks.
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- Patients must have a Karnofsky performance status of greater than or equal to 60.
- Patients must be at least six weeks from radiation therapy. Additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide or carboplatin, 3 weeks from procarbazine, and 2 weeks from last vincristine administration. Patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen) including investigative agents.
- Patients must have adequate bone marrow function (WBC greater than or equal to 3,000/microliter ANC greater than or equal to 1,500/mm(3), platelet count of greater than or equal to 100,000/mm(3), and hemoglobin greater than or equal to 10 gm/dl), adequate liver function (SGOT and bilirubin less than or equal to 2 times ULN), and adequate renal function (creatinine less than or equal to 1.5 mg/dL and/or creatinine clearance greater than or equal to 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion.
- Patients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registration.
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in remission and off of all therapy for that disease for a minimum of 1 year are ineligible.
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate.
- Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with ZD6474. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- A 12 lead electrocardiogram (ECG) to be performed within 2 weeks of trial entry with QTc less than 460 msec.
- Only patients on EIAEDs are to be included in Phase I.
- A normal echocardiogram to be performed within 2 weeks of trial entry.
- Patients with histologically proven malignant primary gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), and malignant glioma/astrocytoma NOS.
- Patients must have an MRI scan performed within 14 days prior to registration.
- Patients having undergone recent resection of a recurrent or progressive tumor, will be eligible four weeks after surgery.
- Patients with high-grade gliomas must have failed prior radiation therapy.
- All patients or their PREVIOUSLY DESIGNATED DPA (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients must be greater than or equal to 18 years old, and must have a life expectancy greater than 8 weeks.
- Patients must have a Karnofsky performance status of greater than or equal to 60.
- Patients must be at least six weeks from radiation therapy. Additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide or carboplatin, 3 weeks from procarbazine, and 2 weeks from last vincristine administration. Patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen) including investigative agents.
- Patients must have adequate bone marrow function (WBC greater than or equal to 3,000/microl, ANC greater than or equal to 1,500/mm(3), platelet count of greater than or equal to 100,000/mm(3), and hemoglobin greater than or equal to 10 gm/dl), adequate liver function (SGOT and bilirubin less than or equal to 2 times ULN), and adequate renal function (creatinine less than or equal to 1.5 mg/dL and/or creatinine clearance greater than or equal to 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion.
- Patients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registration.
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in remission and off of all therapy for that disease for a minimum of 1 year are ineligible.
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate.
- Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with ZD6474. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- A 12 lead electrocardiogram (ECG) to be performed within 2 weeks of trial entry with QTc less than 460 msec.
- Only patients taking NEIAEDs are to be included in Phase II.
- A normal echocardiogram to be performed within 2 weeks of trial entry.
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- Patients who, in the view of the treating physician, have significant active hepatic, renal, or psychiatric diseases are ineligible.
- Active cardiac disease as defined by:
- Significant cardiac event (including symptomatic heart failure or evidence of cardiac ischemia within 3 months of first dose or presence of any cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- Clinically significant arrhythmia (multifocal premature ventricular contraction [PVC], bigeminy, trigeminy, ventricular tachycardia, bradycardia) that is symptomatic or requires treatment (CTCAE v3.0 grade 3), or asymptomatic sustained ventricular tachycardia, at the discretion of the investigator.
- Any concurrent medication that may cause QTc prolongation or induce Torsades de Pointes (See Appendix C, Table 1). Drugs listed in Appendix C, Table 2, that in the investigator s opinion cannot be discontinued are allowed; however, must be monitored closely with additional ECGs and laboratory assessments of electrolytes to ensure the patient s safety.
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- Previous history of QTc prolongation with other medication.
- Congenital long QT syndrome.
- QTc with Bazett's correction that is unmeasurable, or greater than or equal to 460 msec on screening ECG. If a patient has QTc greater than or equal to 460 msec on screening ECG, a second screen ECG may be repeated at least 24 hours apart. The average QTc from the 2 screening ECGs must be less than 460 msec in order for the patient to be eligible for the study. If the patient meets eligibility requirements in this way, the "baseline" QTc for this patient will be the average of the 3 ECGs (screen 1, screen 2, and pre-1st dose).
- Previous history of left ventricular ejection fraction (LVEF) less than 45 percent as measured by multi-gated acquisition scan (MUGA) or by echocardiogram (ECHO) for patients with previous anthracycline therapy (total dose greater than 450 mg/m(2)) or significant cardiovascular disease or chest irradiation, as determined by the investigator.
- A cardiac arrhythmia serious enough to require therapy (i.e. drugs, AID), angina, symptomatic congestive heart failure and/or a cardiac ejection fraction less than 45 percent.
- Prior serious cardiac disease defined as prior coronary bypass surgery, angioplasty, or prior myocardial infarction unless a recent cardiac evaluation (within the last 3 months) demonstrated no significant coronary artery disease (i.e. a negative stress test) and no myocardial wall dysfunction.
- Concurrent use of other standard chemotherapeutics or investigative agents or vasoconstrictors for the treatment of migraine (ergotamine, zolmitriptan, sumatriptan) because of the potential for exacerbation of coronary vasoconstriction.
- Laboratory results sustained at:
- Neutrophils less than 1.5 10(9)/L or platelets less than 100,000/mm(3). Serum creatinine greater than 1.5 x ULRR. Potassium, calcium (ionized calcium or adjusted for albumin), or magnesium concentrations outside normal limits. Supplementation of electrolytes is permitted. Aspartate aminotransferase (AST/SGOT) greater than 2 times ULRR, or AST greater than 5.0 ULRR if judged by the investigator to be related to liver metastases.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg).
- Any currently active gastrointestinal disease with diarrhea that may affect the ability of the patient to absorb the ZD6474 or tolerate diarrhea.
- Currently pregnant or breast feeding.
- Participation in a clinical trial of any investigational agents within 14 days prior to commencing study treatment.
- Patients must be at least six weeks from radiation therapy. Additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide or carboplatin, 3 weeks from procarbazine, and 2 weeks from last vincristine administration. Patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen) including investigative agents.
- Any unresolved toxicity greater than CTC (Version 3.0) grade 1 from previous anti-cancer therapy.
- Any of the following is regarded as a criterion for exclusion from the study:
- Patients who, in the view of the treating physician, have significant active hepatic, renal, or psychiatric diseases are ineligible.
- Active cardiac disease as defined by:
- Significant cardiac event (including symptomatic heart failure or evidence of cardiac ischemia within 3 months of first dose or presence of any cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- Clinically significant arrhythmia (multifocal premature ventricular contraction [PVC], bigeminy, trigeminy, ventricular tachycardia, bradycardia) that is symptomatic or requires treatment (CTCAE grade 3), or asymptomatic sustained ventricular tachycardia.
- Any concurrent medication that may cause QTc prolongation or induce Torsades de Pointes (See Appendix C, Table 1). Drugs listed in Appendix C, Table 2, that in the investigator s opinion cannot be discontinued are allowed; however, must be monitored closely with additional ECGs and laboratory assessments of electrolytes to ensure the patient s safety.
- Previous history of QTc prolongation with other medication.
- Congenital long QT syndrome
- QTc with Bazett's correction that is unmeasurable, or greater than or equal to 460 msec on screening ECG. If a patient has QTc greater than or equal to 460 msec on screening ECG, a second screen ECG may be repeated at least 24 hours apart. The average QTc from the 2 screening ECGs must be less than 460 msec in order for the patient to be eligible for the study. If the patient meets eligibility requiremen...
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase I/II Trial of ZD6474 for Patients With Recurrent High-Grade and Progressive Low-Grade Gliomas
Background:
In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various preclinical tumor models. Given the pronounced neovasculature associated with malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of this neovasculature, ZD6474 represents a potentially promising new therapeutic approach to these otherwise refractory tumors.
Read more
Thus, we now propose a phase I trial of ZD6474 in patients with recurrent and progressive low-grade gliomas who are on P450-inducing anti-epileptic drugs and a phase II trial for patients with recurrent gliomas not taking P450-inducing anti-epileptic drugs.
Objective:
Phase I - To establish the maximally tolerated dose of ZD6474 and to obtain preliminary information regarding the spectrum of toxicities of ZD6474, and to obtain pharmacokinetic data to patients taking EIAED.
Phase I - To obtain preliminary information regarding potential anti-tumor activity of ZD6474 in patients taking EIAED.
Phase II - To establish data regarding the anti-tumor activity of ZD6474 and to collect information regarding the spectrum of toxicities in patients not taking EIAEDs.
Eligibility:
Patients with histologically proven malignant primary gliomas will be eligible for this protocol. Additionally, patients with progressive low-grade gliomas and patients with infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy will also be eligible.
Design:
Phase I - Group B patients will be accrued to the formal dose-escalation phase I trial. Groups of patients with recurrent high-grade gliomas will be accrued to increasingly higher doses of ZD6474 until the MTD is established.
Phase II - Patients will be treated at a dose of 300 mg day, every day, on a 4-week cycle.
Read the detailed description
Background:
In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various preclinical tumor models. Given the pronounced neovasculature associated with malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of this neovasculature, ZD6474 represents a potentially promising new therapeutic approach to these otherwise refractory tumors.
Thus, we now propose a phase I trial of ZD6474 in patients with recurrent and progressive low-grade gliomas who are on P450-inducing anti-epileptic drugs and a phase II trial for patients with recurrent gliomas not taking P450-inducing anti-epileptic drugs.
Objective:
Phase I - To establish the maximally tolerated dose of ZD6474 and to obtain preliminary information regarding the spectrum of toxicities of ZD6474, and to obtain pharmacokinetic data to patients taking EIAED.
Phase I - To obtain preliminary information regarding potential anti-tumor activity of ZD6474 in patients taking EIAED.
Phase II - To establish data regarding the anti-tumor activity of ZD6474 and to collect information regarding the spectrum of toxicities in patients not taking EIAEDs.
Eligibility:
Patients with histologically proven malignant primary gliomas will be eligible for this protocol. Additionally, patients with progressive low-grade gliomas and patients with infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy will also be eligible.
Design:
Phase I - Group B patients will be accrued to the formal dose-escalation phase I trial. Groups of patients with recurrent high-grade gliomas will be accrued to increasingly higher doses of ZD6474 until the MTD is established.
Phase II - Patients will be treated at a dose of 300 mg day, every day, on a 4-week cycle.
- Being tested
- Steroids, ZD6474
- Keywords
- Brain, Tumor, Therapy, Progression, Antiangiogenesis, Brain Tumor, Malignant Glioma
- Medical subject headings
- Glioma, Neoplasms, Disease Progression, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteroidsDrug
ZD6474Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximally tolerated dose of ZD6474 in patients with recurrent high-grade gliomas taking EIAED.
Secondary outcomes (1)
To obtain preliminary information regarding the spectrum of toxicities, and to obtain pharmacokinetic data on ZD6474 administered to patients with recurrent high-grade gliomas taking EIAED.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2006 (estimated)
- Study start29 Dec 2005
- Primary completion27 Feb 2014
- Study completion27 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent High-Grade GliomasStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Teri N Kreisl, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272350
- Sponsor's protocol ID
- 060063
- Other IDs
- 06-C-0063
- Status last verified
- 27 Feb 2014
- First submitted
- 5 Jan 2006
- Last updated
- 5 Dec 2019
- Results posted
- No
Publications
Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, Carey J, Baty B, Kivlin J, et al. Gene for von Recklinghausen neurofibromatosis is in the pericentromeric region of chromosome 17. Science. 1987 May 29;236(4805):1100-2. doi: 10.1126/science.3107130.
PubMed 3107130Bigner SH, Bjerkvig R, Laerum OD. DNA content and chromosomal composition of malignant human gliomas. Neurol Clin. 1985 Nov;3(4):769-84.
PubMed 3001489Moss AR. Occupational exposure and brain tumors. J Toxicol Environ Health. 1985;16(5):703-11. doi: 10.1080/15287398509530780.
PubMed 4093991
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of ZD6474 for Patients With Recurrent High-Grade and Progressive Low-Grade Gliomas
- ClinicalTrials.gov ID
- NCT00272350
- Acronym / sponsor ID
- 060063
- Keywords
- Brain, Tumor, Therapy, Progression, Antiangiogenesis, Brain Tumor, Malignant Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 29 Dec 2005
- Primary completion
- 27 Feb 2014 (actual)
- Study completion
- 27 Feb 2014 (actual)
- First posted
- 5 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various preclinical tumor models. Given the pronounced neovasculature associated with malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of this neovasculature, ZD6474 represents a potentially promising new therapeutic approach to these otherwise refractory tumors.
Thus, we now propose a phase I trial of ZD6474 in patients with recurrent and progressive low-grade gliomas who are on P450-inducing anti-epileptic drugs and a phase II trial for patients with recurrent gliomas not taking P450-inducing anti-epileptic drugs.
Objective:
Phase I - To establish the maximally tolerated dose of ZD6474 and to obtain preliminary information regarding the spectrum of toxicities of ZD6474, and to obtain pharmacokinetic data to patients taking EIAED.
Phase I - To obtain preliminary information regarding potential anti-tumor activity of ZD6474 in patients taking EIAED.
Phase II - To establish data regarding the anti-tumor activity of ZD6474 and to collect information regarding the spectrum of toxicities in patients not taking EIAEDs.
Eligibility:
Patients with histologically proven malignant primary gliomas will be eligible for this protocol. Additionally, patients with progressive low-grade gliomas and patients with infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy will also be eligible.
Design:
Phase I - Group B patients will be accrued to the formal dose-escalation phase I trial. Groups of patients with recurrent high-grade gliomas will be accrued to increasingly higher doses of ZD6474 until the MTD is established.
Phase II - Patients will be treated at a dose of 300 mg day, every day, on a 4-week cycle.
Detailed description
Background:
In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various preclinical tumor models. Given the pronounced neovasculature associated with malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of this neovasculature, ZD6474 represents a potentially promising new therapeutic approach to these otherwise refractory tumors.
Thus, we now propose a phase I trial of ZD6474 in patients with recurrent and progressive low-grade gliomas who are on P450-inducing anti-epileptic drugs and a phase II trial for patients with recurrent gliomas not taking P450-inducing anti-epileptic drugs.
Objective:
Phase I - To establish the maximally tolerated dose of ZD6474 and to obtain preliminary information regarding the spectrum of toxicities of ZD6474, and to obtain pharmacokinetic data to patients taking EIAED.
Phase I - To obtain preliminary information regarding potential anti-tumor activity of ZD6474 in patients taking EIAED.
Phase II - To establish data regarding the anti-tumor activity of ZD6474 and to collect information regarding the spectrum of toxicities in patients not taking EIAEDs.
Eligibility:
Patients with histologically proven malignant primary gliomas will be eligible for this protocol. Additionally, patients with progressive low-grade gliomas and patients with infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy will also be eligible.
Design:
Phase I - Group B patients will be accrued to the formal dose-escalation phase I trial. Groups of patients with recurrent high-grade gliomas will be accrued to increasingly higher doses of ZD6474 until the MTD is established.
Phase II - Patients will be treated at a dose of 300 mg day, every day, on a 4-week cycle.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Patients with histologically proven malignant primary gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), and malignant glioma/astrocytoma NOS. Additionally, patients with progressive low-grade gliomas and patients with infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy.
- Patients must have an MRI scan performed within 14 days prior to registration.
- Patients having undergone recent resection of a recurrent or progressive tumor, will be eligible four weeks after surgery.
- Patients must have failed prior radiation therapy.
- All patients or their PREVIOUSLY DESIGNATED DPA (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired is such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study.
Key exclusion criteria (31 listed)
- Patients who, in the view of the treating physician, have significant active hepatic, renal, or psychiatric diseases are ineligible.
- Significant cardiac event (including symptomatic heart failure or evidence of cardiac ischemia within 3 months of first dose or presence of any cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- Clinically significant arrhythmia (multifocal premature ventricular contraction [PVC], bigeminy, trigeminy, ventricular tachycardia, bradycardia) that is symptomatic or requires treatment (CTCAE v3.0 grade 3), or asymptomatic sustained ventricular tachycardia, at the discretion of the investigator.
- Any concurrent medication that may cause QTc prolongation or induce Torsades de Pointes (See Appendix C, Table 1). Drugs listed in Appendix C, Table 2, that in the investigator s opinion cannot be discontinued are allowed; however, must be monitored closely with additional ECGs and laboratory assessments of electrolytes to ensure the patient s safety.
- Previous history of QTc prolongation with other medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steroids | Drug | – |
| ZD6474 | Drug | – |
Primary outcome
To establish the maximally tolerated dose of ZD6474 in patients with recurrent high-grade gliomas taking EIAED.
1 secondary outcome
To obtain preliminary information regarding the spectrum of toxicities, and to obtain pharmacokinetic data on ZD6474 administered to patients with recurrent high-grade gliomas taking EIAED.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Background: PubMed 3107130Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, Carey J, Baty B, Kivlin J, et al. Gene for von Recklinghausen neurofibromatosis is in the pericentromeric region of chromosome 17. Science. 1987 May 29;236(4805):1100-2. doi: 10.1126/science.3107130.
- Background: PubMed 3001489Bigner SH, Bjerkvig R, Laerum OD. DNA content and chromosomal composition of malignant human gliomas. Neurol Clin. 1985 Nov;3(4):769-84.
- Background: PubMed 4093991Moss AR. Occupational exposure and brain tumors. J Toxicol Environ Health. 1985;16(5):703-11. doi: 10.1080/15287398509530780.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teri N Kreisl, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Steroids and ZD6474 in people with Recurrent High-Grade Gliomas and Progressive Low-Grade Gliomas, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the maximally tolerated dose of ZD6474 in patients with recurrent high-grade gliomas taking EIAED.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00272350, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.