Ph II Bevacizumab + Etoposide for Pts w Recurrent MG
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Duke University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Duke University
Collaborator:
Genentech
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00612430
First received: January 29, 2008
Last updated: August 4, 2009
Last verified: August 2009
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Purpose
Primary Objective to estimate 6-month progression free survival probability of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.
Secondary Objectives To evaluate safety & tolerability of Etoposide + bevacizumab among pts w recurrent malignant glioma.
To evaluate radiographic response, progression free survival & overall survival of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Gliosarcoma |
Drug: Bevacizumab and Etoposide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- 6 mth progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- a.Radiographic response. b.Median progression free survival and overall survival. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Gr 3 or greater, treatment related, non-hematologic toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 59 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Bevacizumab and Etoposide
- Bevacizumab - Avastin
- Etoposide-Etopophos-Toposar-VePesid-VP-16
32 pts w recurrent WHO grade III MG & 27 pts w recurrent WHO grade IV MG will be enrolled in this study. Estimated rate of accrual is 10 pts per month. The estimated date of study completion is 6-9 months from study initiation. Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If pt tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day. The Duke investigators will review all la data & order treatment. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent.
Other Names:
Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + bevacizumab among pts w RMG. Primary endpoint of study is probability of progression-free survival at 6 mths. Important secondary objective is to further assess safety of Etoposide & bevacizumab for pts w RMG.
If study demonstrates that combinatorial regimen of Etoposide + bevacizumab is associated w encouraging anti-tumor activity among pts w RMG, further assessment of regimen in additional ph II & possibly ph III studies, will be considered.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pts have confirmed diagnosis of recurrent/progressive WHO gr III & IV MG
- Age >18 rs
- Interval of >4 wks since prior surgery
- Interval of >4 wks since prior XRT/chemo, unless there is unequivocal evidence of progressive disease & pts have recovered from all anticipated toxicity of most recent therapy;
- Karnofsky performance status score >60
- Hematocrit >29 percent, ANC >1,500 cells/microliter, platelets >100,000 cells/microliter
- Serum creatinine <1.5 mg/dl, BUN <25 mg/dl, serum SGOT & bilirubin <1.5 x ULN
- For pts on corticosteroids, they have been on astable dose for 1wk prior to entry
- Signed informed consent approved by IRB prior to pt entry
- If sexually active, pts must agree to take contraceptive measures for duration of treatments.
Exclusion Criteria:
- Prior therapy w either bevacizumab/etoposide
- >3 prior recurrences
- Pregnancy/breast feeding
- Co-medication w immuno-suppressive agents other than corticosteroids including but not limited to cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil
- Evidence of CNS hemorrhage on baseline MRI on CT scan
- Pts who require therapeutic anti-coagulation
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics & psychiatric illness/social situations that would limit compliance w study requirements, or disorders associated w significant immunocompromised state
- Pts w another primary malignancy that has required treatment <past year
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612430
Locations
| United States, North Carolina | |
| Duke University Health System | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Duke University
Genentech
Investigators
| Principal Investigator: | David A. Reardon, MD | Duke University Health System |
More Information
Additional Information:
No publications provided by Duke University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David A. Reardon, MD, Duke University Health System |
| ClinicalTrials.gov Identifier: | NCT00612430 History of Changes |
| Other Study ID Numbers: | 00000379 |
| Study First Received: | January 29, 2008 |
| Last Updated: | August 4, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Glioblastoma Gliosarcoma GBM MG Brain tumor Bevacizumab Avastin Etoposide |
VP-16 Etopophos Toposar VePesid Glioblastoma multiforme Recurrent GBM Anaplastic astrocytoma Malignant glioma |
Additional relevant MeSH terms:
|
Glioblastoma Gliosarcoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Etoposide |
Etoposide phosphate Bevacizumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 13, 2013