Central Nervous System TumorsPhase 1NCT01052363
OXC401-PO1s/WVU 1309 - A Pilot Study of Fosbretabulin With Bevacizumab in Recurrent High-Grade Gliomas
A Phase 1 study testing Bevacizumab, CA4P in people with Central Nervous System Tumors, run by West Virginia University at 1 site in United States.
Trial summary
Pilot Trial of CA4P with Avastin in Recurrent Gliomas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Tumors
- What is being tested?
- Bevacizumab, CA4P
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to not given
- 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 must have histologically or cytologically confirmed grade III Anaplastic gliomas (including anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma) or Grade IV Glioblastoma multiforme.
- Recurrence or progression after failing first line treatment of temozolomide chemotherapy and radiation. Patient who failed additional lines of treatment are eligible for participating in the trial. Patients must have measurable disease, defined as having contrast enhancing measurable disease on MRI of brain. Baseline MRI should be done no more than 2 weeks from starting treatment.
- At least 4 weeks since prior chemotherapy or radiation therapy, 4 weeks if the last regimen included BCNU.
- Age greater than 18 years. Because no dosing or adverse event data are currently available on the use of fosbretabulin in combination with bevacizumab in patients less than 18 years of age, children are excluded from this study.
- Life expectancy of greater than 3 months.
- ECOG performance status 0-2 Karnofsky greater than 60%).
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- Patients must have normal organ and marrow function as defined.
- The effects of fosbretabulin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because vascular disrupting agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant (including female partners of male study participants) or suspect she is pregnant while participating in this study, she should inform the Investigator and her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients with prior treatment using bevacizumab.
- Patients should not have received any other investigational agents within 4 weeks.
- History of abdominal fistula, GI perforation or intra-abdominal abscess within the last 6 months.
- Coagulopathy or bleeding diathesis. Patients on therapeutic dose of anticoagulation are excluded from the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Also, MI/unstable angina within 6 months; stroke/TIA within 1 year; symptomatic claudication within 1 year; abnormalities on ECG including prolonged QTc interval (i.e. > 450 ms for males and > 470 ms for females), new Q-wave, RBBB, LBBB,ST-segment depression.
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- Grade 3 proteinuria (> 3.5 g protein/24 hours)
- Uncontrolled hypertension (blood pressure >150/100 during Screening)
- Clinically significant peripheral vascular disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fosbretabulin or other agents used in the study.
- Since dilantin induces the P450 system and the effect this will have on fosbretabulin or bezvacazimab is not known, patients that are on seizure prophylaxis with dilantin will not be eligible. Switching the seizure prophylaxis to noninducers of the P450 system such as levetiracetam is acceptable. Patients must be off dilantin for one week before starting this clinical trial. Additionally fosbretabulin has the potential to interact with drugs metabolized by CYP2C19 which includes barbiturates, diazepam and valproic acid. However the clinical significance of these interactions is not known.
- Pregnant women are excluded from this study because fosbretabulin is a vascular disrupting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with fosbretabulin, breastfeeding should be discontinued if the mother is treated with fosbretabulin.
- HIV-positive patients on combination antiretroviral therapy are ineligible Because of the potential for pharmacokinetic interactions with fosbretabulin. In addition,these patients are at increased risk of lethal infections when treated with marrowsuppressive therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
MBRCC, West Virginia University
Morgantown, West Virginia, 26506
About this study
Pilot Trial of CA4P with Avastin in Recurrent Gliomas
Read the detailed description
The purpose of this study is to see if fosbretabulin, the drug being studied, combined with bevacizumab will help your brain cancer and if using these drugs together is safe.
- Conditions
- Central Nervous System Tumors
- Being tested
- Bevacizumab, CA4P
- Keywords
- CNS tumors
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab, CA4PDrug
| Study group | Role | What they receive |
|---|---|---|
| CA4P + Avastin | Experimental | Not described Receives: Drug: Bevacizumab, CA4P |
| Avastin + CA4P | Experimental | Not described Receives: Drug: Bevacizumab, CA4P |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJan 2010
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramin Altaha, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052363
- Sponsor's protocol ID
- WVU1309
- Status last verified
- Feb 2017
- First submitted
- 19 Jan 2010
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OXC401-PO1s/WVU 1309 - A Pilot Study of Fosbretabulin With Bevacizumab in Recurrent High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT01052363
- Acronym / sponsor ID
- WVU1309
- Conditions
- Central Nervous System Tumors
- Keywords
- CNS tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jan 2010
- First posted
- 20 Jan 2010 (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.
Pilot Trial of CA4P with Avastin in Recurrent Gliomas
Detailed description
The purpose of this study is to see if fosbretabulin, the drug being studied, combined with bevacizumab will help your brain cancer and if using these drugs together is safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA4P + Avastin | Experimental | Drug: Bevacizumab, CA4P |
| Avastin + CA4P | Experimental | Drug: Bevacizumab, CA4P |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histologically or cytologically confirmed grade III Anaplastic gliomas (including anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma) or Grade IV Glioblastoma multiforme.
- Recurrence or progression after failing first line treatment of temozolomide chemotherapy and radiation. Patient who failed additional lines of treatment are eligible for participating in the trial. Patients must have measurable disease, defined as having contrast enhancing measurable disease on MRI of brain. Baseline MRI should be done no more than 2 weeks from starting treatment.
- At least 4 weeks since prior chemotherapy or radiation therapy, 4 weeks if the last regimen included BCNU.
- Age greater than 18 years. Because no dosing or adverse event data are currently available on the use of fosbretabulin in combination with bevacizumab in patients less than 18 years of age, children are excluded from this study.
- Life expectancy of greater than 3 months.
Key exclusion criteria (13 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients with prior treatment using bevacizumab.
- Patients should not have received any other investigational agents within 4 weeks.
- History of abdominal fistula, GI perforation or intra-abdominal abscess within the last 6 months.
- Coagulopathy or bleeding diathesis. Patients on therapeutic dose of anticoagulation are excluded from the study.
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 |
|---|---|---|
| Bevacizumab, CA4P | Drug | Avastin + CA4P, CA4P + Avastin |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Ramin Altaha, MD principal investigator
West Virginia University
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 Bevacizumab, CA4P in people with Central Nervous System Tumors, run by West Virginia University 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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 9 Feb 2017. 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 was withdrawn before enrolling participants, so there are no results.
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 9 Feb 2017.