Anaplastic AstrocytomaPhase 2NCT00606008
A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma
A Phase 2 study testing Sunitinib Malate in people with Anaplastic Astrocytoma and Glioblastoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
We are asked patients to take part in this study because they had recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). The purposes of this study are: To see if Sutent has any change on the patient and their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Astrocytoma, Glioblastoma
- What is being tested?
- Sunitinib Malate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade ≤1.
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤3 x local laboratory upper limit of normal (ULN), or AST and ALT ≤3 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin ≤1.5 x ULN
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100,000/µL
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- Hemoglobin ≥9.0 g/dL
- Serum calcium ≤12.0 mg/dL
- Serum creatinine ≤1.5 x ULN
- Patients must have histologically or neuroradiographically recurrent anaplastic astrocytoma (AA) or glioblastoma (GBM). Must have had prior pathologic confirmation of primary tumor histology.
- Must be ≥ 18 years old.
- Must have a Karnofsky performance status (KPS) ≥ 60%
- Measurable disease per MacDonald criteria required using contrast enhanced cranial MRI.
- Life expectancy ≥ 12 weeks.
- Must sign and date an Institutional Review Board (IRB) approved informed consent stating that he or she is aware of the neoplastic nature of the disease. Must willingly provide written consent after being informed of procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and accessible for follow-up.
- Have undergone surgery documenting tumor histology though repeat surgery at time of tumor recurrence is not mandatory.
- Have received prior external beam radiotherapy.
- Patients may have received one or two prior salvage chemotherapy and may have received adjuvant chemotherapy following initial surgery.
- May not have received prior stereotactic radiotherapy.
- May have been treated with Gliadel at initial surgery only.
Who cannot join
- Major surgery or radiation therapy within 4 weeks of starting study treatment.
- NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment.
- History of or known spinal cord compression or carcinomatous meningitis, or evidence of leptomeningeal disease on screening CT or MRI scan.
- Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
- Prolonged QTc interval on baseline EKG.
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- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range with medication.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection.
- Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
- Concomitant use of ketoconazole and other agents known to inhibit Cytochrome P450 3A4 (CYP3A4).
- Concomitant use of theophylline and phenobarbital and/or other agents metabolized by the cytochrome P450 system.
- Ongoing treatment with therapeutic doses of Coumadin (low dose up to 2 mg po daily for thrombo-prophylaxis is allowed).
- Pregnancy or breastfeeding. Female subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy. Female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of investigator would make patient inappropriate for entry into this study.
- Patients having been treated with 3 or more salvage regimens.
- Patients with a second active malignancy or diagnosis of other cancer within 3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.
- Mentally incapacitated patients or psychiatric illness that would prevent them from giving informed consent.
- Poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within previous 6 months, or serious uncontrolled cardiac arrhythmia.
- Known to be HIV positive or to have an AIDS-related illness.
- Patients with an active infection that is not adequately controlled with antibiotics.
- Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Known sensitivity to any of the products to be administered during treatment.
- Currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme
We are asked patients to take part in this study because they had recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).
The purposes of this study are:
- To see if Sutent has any change on the patient and their cancer.
- To see if Sutent will slow or stop the growth of their tumor.
- To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved to treat patients with a gastrointestinal stromal tumor after the disease worsened while taking another medicine called imatinib mesylate or when imatinib mesylate cannot be taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help patients with this disease live longer.
Read the detailed description
Trial patients received sunitinib 50 mg daily for 4 weeks without regard to meals, followed by a 2-week rest period. This 6-week regimen constituted 1 cycle. Patients were treated for up to 9 cycles [~ year) or until disease progression or death or if persistent toxicities occurred. Complete blood count with differential, complete metabolic profile, neurologic exam, and brain magnetic resonance imaging (MRI) with contrast were obtained after each cycle. Toxicity assessments were obtained after each cycle. Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0.
SCHEDULE OF EVENTS - PROTOCOL ACTIVITIES
<14 Days Prior to Initial Study Treatment:
- Neurological/Oncological History
- Neurological Examination
- Height/Weight/Body Surface Area
- Performance Status
- Quality of Life (QOL) FACT-L
- Laboratory Studies; complete blood count (CBC), Differential, Platelets, prothrombin time/partial thromboplastin time (PT/PTT), international normalized ratio (INR), Serum Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), Total Bilirubin, alkaline phosphatase (AlkPHs), Pregnancy Test, electrocardiogram (EKG)
- Cranial MRI or CT with and without contrast
- Multiple uptake gated acquisition (MUGA) Scan
Day 1, At the Beginning of Each Treatment Cycle:
- Adverse Event Assessment
- Laboratory Studies; CBC, Differential, Platelets
Every Cycle, Days 42-45 (within 3 days of next scheduled Sutent treatment):
- Neurological/Oncological History
- Neurological Examination
- Height/Weight/Body Surface Area
- Performance Status
- QOL FACT-L
- Laboratory Studies; Serum Creatinine, BUN, ALT, AST, LDH, Total Bilirubin, AlkPHs
- Cranial MRI or CT with and without contrast
- Survival
At Off Study:
- Performance Status
- Cranial MRI or CT with and without contrast
- Survival
- Conditions
- Anaplastic Astrocytoma, Glioblastoma
- Being tested
- Sunitinib Malate
- Keywords
- Sutent
- Medical subject headings
- Astrocytoma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib MalateDrug
Also called Sutent, SU011248
Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.
| Study group | Role | What they receive |
|---|---|---|
| Sutent Treatment | Experimental | Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Receives: Drug: Sunitinib Malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse
Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.
Measured: 6 Months
Secondary outcomes (2)
Best Overall Response
To estimate best response rates (proportion of patients who ever had a radiographic response equal to or better than stable disease during course assessment).
Measured: 12 Months
Number of Participants With Related Grade 3 and Greater Adverse Events
To evaluate toxicities associated with sunitinib treatment (grade 3 and greater toxicities).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anaplastic AstrocytomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Edward Pan, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606008
- Sponsor's protocol ID
- MCC-14916
- Status last verified
- Sep 2012
- First submitted
- 21 Jan 2008
- Last updated
- 19 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00606008
- Acronym / sponsor ID
- MCC-14916
- Conditions
- Anaplastic Astrocytoma, Glioblastoma
- Keywords
- Sutent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Feb 2008 (estimated)
- Results
- Posted 31 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are asked patients to take part in this study because they had recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).
The purposes of this study are:
- To see if Sutent has any change on the patient and their cancer.
- To see if Sutent will slow or stop the growth of their tumor.
- To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved to treat patients with a gastrointestinal stromal tumor after the disease worsened while taking another medicine called imatinib mesylate or when imatinib mesylate cannot be taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help patients with this disease live longer.
Detailed description
Trial patients received sunitinib 50 mg daily for 4 weeks without regard to meals, followed by a 2-week rest period. This 6-week regimen constituted 1 cycle. Patients were treated for up to 9 cycles [~ year) or until disease progression or death or if persistent toxicities occurred. Complete blood count with differential, complete metabolic profile, neurologic exam, and brain magnetic resonance imaging (MRI) with contrast were obtained after each cycle. Toxicity assessments were obtained after each cycle. Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0.
SCHEDULE OF EVENTS - PROTOCOL ACTIVITIES
<14 Days Prior to Initial Study Treatment:
- Neurological/Oncological History
- Neurological Examination
- Height/Weight/Body Surface Area
- Performance Status
- Quality of Life (QOL) FACT-L
- Laboratory Studies; complete blood count (CBC), Differential, Platelets, prothrombin time/partial thromboplastin time (PT/PTT), international normalized ratio (INR), Serum Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), Total Bilirubin, alkaline phosphatase (AlkPHs), Pregnancy Test, electrocardiogram (EKG)
- Cranial MRI or CT with and without contrast
- Multiple uptake gated acquisition (MUGA) Scan
Day 1, At the Beginning of Each Treatment Cycle:
- Adverse Event Assessment
- Laboratory Studies; CBC, Differential, Platelets
Every Cycle, Days 42-45 (within 3 days of next scheduled Sutent treatment):
- Neurological/Oncological History
- Neurological Examination
- Height/Weight/Body Surface Area
- Performance Status
- QOL FACT-L
- Laboratory Studies; Serum Creatinine, BUN, ALT, AST, LDH, Total Bilirubin, AlkPHs
- Cranial MRI or CT with and without contrast
- Survival
At Off Study:
- Performance Status
- Cranial MRI or CT with and without contrast
- Survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sutent Treatment | Experimental | Drug: Sunitinib MalateSutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade ≤1.
- Adequate organ function as defined by the following criteria:
- Patients must have histologically or neuroradiographically recurrent anaplastic astrocytoma (AA) or glioblastoma (GBM). Must have had prior pathologic confirmation of primary tumor histology.
- Must be ≥ 18 years old.
- Must have a Karnofsky performance status (KPS) ≥ 60%
Key exclusion criteria (24 listed)
- Major surgery or radiation therapy within 4 weeks of starting study treatment.
- NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment.
- History of or known spinal cord compression or carcinomatous meningitis, or evidence of leptomeningeal disease on screening CT or MRI scan.
- Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
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 |
|---|---|---|
| Sunitinib MalateAlso: Sutent, SU011248Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study. | Drug | Sutent Treatment |
Primary outcome
Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse
Time frame: 6 Months
Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.
2 secondary outcomes
Best Overall Response
Time frame: 12 Months
Number of Participants With Related Grade 3 and Greater Adverse Events
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Edward Pan, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib Malate in people with Anaplastic Astrocytoma and Glioblastoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 21 inclusion and 24 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 19 Nov 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2012.