Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas
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ClinicalTrials.gov Identifier: NCT00612339 |
Recruitment Status
:
Completed
First Posted
: February 11, 2008
Results First Posted
: September 10, 2012
Last Update Posted
: May 27, 2013
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Primary objective- To determine efficacy of Avastin, 10 mg/kg every other week, in combination with standard 5-day temozolomide in terms of response rate.
Secondary objective- To determine safety of Avastin & Temozolomide in unresectable glioblastoma patients
Condition or disease | Intervention/treatment | Phase |
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Glioblastoma Gliosarcoma | Drug: Avastin and Temozolomide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Avastin in Combination With Temozolomide for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Avastin and Temozolomide
Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
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Drug: Avastin and Temozolomide
This is Phase II study with the combination of Avastin & Temozolomide for unresectable or multifocal WHO grade IV malignant glioma patients. Patients will receive up to 4 cycles of Avastin & Temozolomide . Avastin administered at 10 mg/kg every 14 days beginning minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide will be dosed at 200 mg/m2 daily x 5 days in 28-day cycle. Patients will have baseline MRI & repeat MRI every 4 weeks. If there is no evidence of disease progression after each cycle, or unacceptable toxicity, or as determined by investigators, patient non-compliance or patient withdraws consent to continue therapy & requests discontinuation, patients will receive up to 4 cycles of Avastin & Temozolomide, then proceed with standard XRT therapy, & future therapy after 4 cycles will be at discretion of patient & treating physicians.
Other Names:
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- Response Rate [ Time Frame: 4 months ]The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients have histologically confirmed diagnosis of WHO gr IV primary malignant glioma. Patients will be unresectable or have multifocal disease.
- Age ≥ 18years & life expectancy of >12 weeks
- Evidence of measurable primary CNS neoplasm on contrast enhanced MRI.
- Interval of <1 week between prior biopsy/4 weeks from surgical resection & enrollment on protocol
- Karnofsky ≥60%
- Hemoglobin ≥9g/dl, ANC ≥1,500 cells/microliter, platelets ≥125,000 cells/microliter
- Serum creatinine ≤1.5 mg/dl, serum SGOT & bilirubin ≤1.5 x ULN
- For patients on corticosteroids, they must have been on stable dose for 1 week prior to entry, if clinically possible, & dose should not be escalated over entry dose level
- Signed informed consent approved by IRB prior to patient entry
- No evidence of > grade 1 CNS hemorrhage on baseline MRI/CT scan
- If sexually active, patients will take contraceptive measures for duration of treatments
Exclusion Criteria:
- Pregnancy/breast feeding
- Co-medication that may interfere with study results
- Active infection requiring IV antibiotics
- Prior or current Treatment w XRT/chemo for brain tumor, irrespective of grade of tumor
- Evidence of > grade 1 CNS hemorrhage on baseline MRI or CT scan
Avastin-Specific Concerns:
- Inadequately controlled hypertension
- Any prior history of hypertensive crisis/hypertensive encephalopathy
- New York Heart Association Grade II or > congestive heart failure
- History of myocardial infarction/unstable angina < 6 months prior to study enrollment
- History of stroke/transient ischemic attack < 6 months prior to study enrollment
- Significant vascular disease
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis/coagulopathy
- Major surgical procedure, open biopsy,/significant traumatic injury within 28 days prior to study enrollment/anticipation of need for major surgical procedure during course of study
- Core biopsy/other minor surgical procedure, excluding placement of vascular access device, <7 days prior to study enrollment
- History of abdominal fistula, GI perforation, /intra-abdominal abscess <6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by either
- UPC ratio ≥1.0 at screening OR
- Urine dipstick for proteinuria ≥2+
- Known hypersensitivity to any component of Avastin
- Pregnant/lactating. Use of effective means of contraception in subjects of child-bearing potential
- Current, ongoing treatment with full-dose warfarin or its equivalent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612339
United States, North Carolina | |
Duke University Health System | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Katherine B Peters, MD, PhD | Duke University Health System |
Additional Information:
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00612339 History of Changes |
Other Study ID Numbers: |
Pro00001022 |
First Posted: | February 11, 2008 Key Record Dates |
Results First Posted: | September 10, 2012 |
Last Update Posted: | May 27, 2013 |
Last Verified: | September 2012 |
Keywords provided by Duke University:
Glioma Temozolomide Temodar Avastin Bevacizumab GBM |
Gliosarcoma Multifocal GBM Brain tumor Unresectable GBM Glioblastoma multiforme |
Additional relevant MeSH terms:
Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Bevacizumab |
Temozolomide Dacarbazine Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |