OXC401-PO1s/WVU 1309 - A Pilot Study of Fosbretabulin With Bevacizumab in Recurrent High-Grade Gliomas
Primary Purpose
Central Nervous System Tumors
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab, CA4P
Sponsored by
About this trial
This is an interventional treatment trial for Central Nervous System Tumors focused on measuring CNS tumors
Eligibility Criteria
Inclusion Criteria:
- 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%).
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- MBRCC, West Virginia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CA4P + Avastin
Avastin + CA4P
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01052363
First Posted
January 19, 2010
Last Updated
February 7, 2017
Sponsor
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT01052363
Brief Title
OXC401-PO1s/WVU 1309 - A Pilot Study of Fosbretabulin With Bevacizumab in Recurrent High-Grade Gliomas
Official Title
OXC401-PO1s/WVU 1309 - A Pilot Study of Fosbretabulin With Bevacizumab in Recurrent High-Grade Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
January 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Virginia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Tumors
Keywords
CNS tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CA4P + Avastin
Arm Type
Experimental
Arm Title
Avastin + CA4P
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab, CA4P
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%).
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramin Altaha, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MBRCC, West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OXC401-PO1s/WVU 1309 - A Pilot Study of Fosbretabulin With Bevacizumab in Recurrent High-Grade Gliomas
We'll reach out to this number within 24 hrs