A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
This study is currently recruiting participants.
Verified December 2012 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01743950
First received: November 27, 2012
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioma |
Drug: Bevacizumab Radiation: PRDR |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- Overall survival [ Time Frame: end of study, which will be an average of 12 months ] [ Designated as safety issue: No ]time of first dose of PDRD+ Bevacizumab until time of death
Secondary Outcome Measures:
- safety profile [ Time Frame: assessed every two weeks prior to each bevacizumab infusion while on treatment then 30 post completion of therapy ] [ Designated as safety issue: Yes ]time of first dose of PDRD+ Bevacizumab until time of death. All changes from baseline assessment will be recorded until 30 days post last dose of bevacizumab. In addition any late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.
- progression free survival [ Time Frame: at 3months for bevacizumab exposed patients, at 6 and 12 months for all patients ] [ Designated as safety issue: No ]will be determined based on clinical and radiographic evidence
- neurologic changes [ Time Frame: baseline and then approximately every 8 weeks for 18 months ] [ Designated as safety issue: No ]will be assessed by physician with mini-mental exam and a FACT BR completed by the patient
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bevacizumab naive recurrent grade IV gliomas
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Drug: Bevacizumab
10mg/kg every 2weeks.
Radiation: PRDR
daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions
Other Name: re-irradiation
|
|
Active Comparator: Bevacuzumab exposed and refractive grade IV gliomas
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Drug: Bevacizumab
10mg/kg every 2weeks.
Radiation: PRDR
daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions
Other Name: re-irradiation
|
|
Active Comparator: Bevacizumab naive recurrent grade III gliomas
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Drug: Bevacizumab
10mg/kg every 2weeks.
Radiation: PRDR
daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions
Other Name: re-irradiation
|
|
Active Comparator: Bevacizumab exposed and refractive grade III gliomas
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
|
Drug: Bevacizumab
10mg/kg every 2weeks.
Radiation: PRDR
daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions
Other Name: re-irradiation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed diagnose of a grade WHO grade III or IV glioma
- Recurrent disease based on combination of clinical, imaging or histologic confirmation
- Must have previously received radiation and temozolomide to treat their glioma
- Bevacizumab naive patients must be > 6months post completion of initial radiation therapy
- Bevacizumab exposed patients must be > 3months post completion of initial radiation therapy
- Age must be >18years, KPS must be greater than 60
- Hematology, chemistry and a urinalysis must meet protocol specified criteria
Exclusion Criteria:
- Pregnant or breastfeeding
- May not be on full dose anti-coagulation therapy, Low molecular weight heparin is ok
- Uncontrolled hypertension (>140/90mmHg)
- Prior malignancy unless treated >1 year prior to study and have been without treatment and disease free for 1 yr
- active second malignancy unless non-melanoma skin cancer or cervical cancer in situ
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743950
Contacts
| Contact: Diana Trask, BS | 608-263-9528 | trask@humonc.wisc.edu |
| Contact: Nick Anger, BS | 608-262-8649 | anger@humonc.wisc.edu |
Locations
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: Steve Howard, MD | |
| Principal Investigator: H. Ian Robins, MD, Ph.D | |
Sponsors and Collaborators
University of Wisconsin, Madison
Genentech
Investigators
| Principal Investigator: | Steve Howard, MD | University of Wisconsin, Madison |
| Principal Investigator: | H. Ian Robins, MD, Ph.D | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01743950 History of Changes |
| Other Study ID Numbers: | CO11374 |
| Study First Received: | November 27, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Wisconsin, Madison:
|
Glioblastoma anaplastic glioma |
Additional relevant MeSH terms:
|
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Bevacizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013