Brain and Central Nervous System TumorsPhase 1/2NCT00004868
SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy
A Phase 1/2 study testing semaxanib in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 12 sites in United States.
Trial summary
RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- semaxanib
- How many people
- Not given
- Where
- 12 sitesUnited States
- Study dates
- 24 Mar 2000to 15 Sep 2005
- Phase
- Phase 1/2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven supratentorial malignant primary glioma, including:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant astrocytoma not otherwise specified
- Benign or malignant meningiomas, including brain and spinal meningiomas
- Patients with meningiomas are excluded from phase II portion of study
- Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI
- Must have failed prior radiotherapy
- Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days
- Must be on stable (unchanged) dose of steroids for at least 5 days before scans
- Phase II:
- Must have completed radiotherapy at least 2 months prior to enrollment
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 8 weeks
Hematopoietic:
- WBC at least 2,300/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL (transfusion allowed)
Hepatic:
- SGOT less than 2.5 times upper limit of normal
- Bilirubin normal
- No significant active hepatic disease
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- No significant active renal disease
Cardiovascular:
- No uncompensated coronary artery disease on ECG or physical examination
- No history of myocardial infarction or severe/unstable angina within the past 6 months
- No deep venous or arterial thrombosis within the past 3 months
Pulmonary:
- No pulmonary embolism within the past 3 months
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 2 months after study
- No other serious concurrent illness
- No significant active psychiatric disease
- No diabetes mellitus with severe peripheral vascular disease
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No serious active infection
- No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered
- No concurrent immunotherapy
Chemotherapy:
- Phase I:
- No more than 2 prior chemotherapy regimens for recurrent disease
- Phase II:
- No more than 1 prior chemotherapy regimen for recurrent disease
- At least 2 weeks since prior vincristine
- At least 6 weeks since prior nitrosoureas
- At least 3 weeks since prior procarbazine
- Recovered from prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered
Radiotherapy:
- See Disease Characteristics
- No concurrent radiotherapy
Surgery:
- Recovered from prior surgery
- Recent prior resection of recurrent or progressive tumor allowed
Other:
- No other concurrent investigational agents
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Neuro-Oncology Branch
Bethesda, Maryland, 20892
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
About this study
Official title: A Phase I/II Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas
RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.
Read the detailed description
OBJECTIVES: Phase I:
- Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant glioma who are, as well as those who are not, taking enzyme-inducing antiepileptic drugs.
- Determine the toxic effects (safety profile) of this drug in this patient population.
- Characterize the pharmacokinetics of this drug in these patients.
- Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo, including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.
Phase II:
- Determine the efficacy of SU5416, in terms of 6-month progression-free survival, in patients with recurrent high-grade glioma.
- Determine, further, the safety profile of the phase II dose of this drug in this patient population.
- Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (no vs yes).
Patients receive SU5416 IV on days 1 and 4 weekly for 4 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD has been determined, additional patients are accrued to the phase II portion of the study. These patients receive SU5416 IV, as in the phase I portion, at the appropriate MTD established in phase I.
Patients are followed for survival.
PROJECTED ACCRUAL: At least 30 patients will be accrued for the phase I dose-escalation portion of this study within 10 months. An additional 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for the phase II portion of this study within 6-8 months.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- semaxanib
- Keywords
- recurrent adult brain tumor, adult meningioma, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult grade III meningioma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Meningioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaxanibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2003 (estimated)
- Study start24 Mar 2000
- Primary completion15 Sep 2004
- Study completion15 Sep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Howard A. Fine, MD, Study chair, NCI - Neuro-Oncology Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004868
- Sponsor's protocol ID
- NABTC-9902
- Other IDs
- CDR0000067527, MSKCC-01045, NCI-00-C-0173
- Status last verified
- Jun 2018
- First submitted
- 7 Mar 2000
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas
- ClinicalTrials.gov ID
- NCT00004868
- Acronym / sponsor ID
- NABTC-9902
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult meningioma, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult grade III meningioma, adult giant cell glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Mar 2000 (actual)
- Primary completion
- 15 Sep 2004 (actual)
- Study completion
- 15 Sep 2005 (actual)
- First posted
- 23 May 2003 (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.
RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.
Detailed description
OBJECTIVES: Phase I:
- Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant glioma who are, as well as those who are not, taking enzyme-inducing antiepileptic drugs.
- Determine the toxic effects (safety profile) of this drug in this patient population.
- Characterize the pharmacokinetics of this drug in these patients.
- Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo, including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.
Phase II:
- Determine the efficacy of SU5416, in terms of 6-month progression-free survival, in patients with recurrent high-grade glioma.
- Determine, further, the safety profile of the phase II dose of this drug in this patient population.
- Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (no vs yes).
Patients receive SU5416 IV on days 1 and 4 weekly for 4 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD has been determined, additional patients are accrued to the phase II portion of the study. These patients receive SU5416 IV, as in the phase I portion, at the appropriate MTD established in phase I.
Patients are followed for survival.
PROJECTED ACCRUAL: At least 30 patients will be accrued for the phase I dose-escalation portion of this study within 10 months. An additional 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for the phase II portion of this study within 6-8 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| semaxanib | Drug | – |
Primary outcome
Not reported in the source record.
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 27 Jun 2018.
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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.
Howard A. Fine, MD study chair
NCI - Neuro-Oncology Branch
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing semaxanib in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 12 sites 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?
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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 combined 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.
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?
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.
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 27 Jun 2018.