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Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glioblastoma Multiforme; Gliosarcoma

Intervention: Avastin (Drug); Temozolomide (Drug); Irinotecan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Katy Peters

Official(s) and/or principal investigator(s):
Katherine B Peters, MD, PhD, Principal Investigator, Affiliation: Duke University

Summary

The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin, temozolomide and irinotecan in unresectable glioblastoma patients. This is a phase II study with the combination of Avastin, temozolomide and irinotecan for unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan. Approximately 41 subjects will take part in this study at Duke.

Clinical Details

Official title: Avastin in Combination With Temozolomide and Irinotecan for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response Rate

Secondary outcome:

Incidence and Severity of Central Nervous System (CNS) Hemorrhage and Systemic Hemorrhage

Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities

Median Progression-free Survival (PFS)

Median Overall Survival (OS)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have histologically confirmed diagnosis of WHO grade IV primary

malignant glioma (glioblastoma multiforme or gliosarcoma). Patients will be unresectable or have multifocal disease.

- Age > or = to 18 years and a life expectancy of >12 weeks.

- Evidence of measurable primary Central Nervous System (CNS) neoplasm on contrast

enhanced MRI.

- An interval of at least one week between prior biopsy or four weeks from surgical

resection and enrollment on this protocol.

- Karnofsky > or = to 60%.

- Hemoglobin > or = to 9g/dl, absolute neutrophil count (ANC) > or = to 1,500

cells/microliter, platelets > or = to 125,000 cells/microliter.

- Serum creatinine ≤ 1. 5 mg/dl, serum serum glutamic oxaloacetic transaminase (SGOT)

and direct bilirubin ≤ 1. 5 times upper limit of normal (if the total bilirubin is greater than or equal to 1. 5 x the upper limit of normal, then the direct bilirubin must be ≤ 1. 5 x the upper limit of normal).

- Signed informed consent approved by the Institutional Review Board prior to patient

entry.

- If sexually active, patients will take contraceptive measures for the duration of the

treatments. Exclusion Criteria:

- Pregnancy or breast feeding

- Co-medication that may interfere with study results; e. g. immuno-suppressive agents

other than corticosteroids.

- Active infection requiring IV antibiotics.

- Treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the

grade of the tumor.

- Evidence of > grade 1 CNS hemorrhage on baseline MRI or CT scan.

Avastin-specific Exclusion Criteria:

- Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or

diastolic blood pressure > 100 mmHg on antihypertensive medications)

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to study

enrollment

- History of stroke or transient ischemic attack within 6 months prior to study

enrollment

- Significant vascular disease (e. g., aortic aneurysm, aortic dissection)

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days

prior to study enrollment or anticipation of need for major surgical procedure during the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular

access device, within 7 days prior to study enrollment

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal

abscess within 6 months prior to study enrollment

- Serious, non-healing wound, ulcer, or bone fracture

- Proteinuria at screening as demonstrated by either urine protein: creatinine (UPC)

ratio > or = to 1. 0 at screening OR urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).

- Known hypersensitivity to any component of Avastin

- Pregnant (positive pregnancy test) or lactating. Use of effective means of

contraception (men and women) in subjects of child-bearing potential

Locations and Contacts

The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information

The Preston Robert Tisch Brain Tumor Center

Starting date: November 2009
Last updated: February 5, 2014

Page last updated: August 23, 2015

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