Clinical trial NCT01115491: A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
Official title: A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Histological diagnosis of glioblastoma multiforme (GBM) documented by surgical resection or biopsy.
* They should be patients in a first relapse treated with radiotherapy and chemotherapy and chemotherapy based on temozolomide 150-200 mg/m2 on days 1 to 5 every 28 days (Stupp regimen) for at least three cycles. At least 4 weeks must have lapsed since previous chemotherapy and 3 months since the last dose of radiotherapy.
* Use of an effective contraceptive method by patients and their partners.
* Stable or decreasing corticosteroid dose for the five days prior to study entry
* Adequate hematological function
* Adequate liver function
* Adequate kidney function

Exclusion Criteria:

* Signs of recent bleeding at the MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving bleeding changes related to surgery, and presence of punctate hemorrhage in the tumor will be allowed to participate in the study.
* Prior treatment with bevacizumab
* Poorly controlled arterial hypertension
* History of hypertensive crises or hypertensive encephalopathy
* New York Health Association (NYHA) Class II or higher congestive heart failure
* History of myocardial infarction or unstable angina pectoris within six months of study entry
* History of stroke or TIA within six months of study entry
* Significant vascular disease within six months of study entry
* History of hemoptysis \> grade 2 according to the NCI CTC criteria within one month of study entry
* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgery, open biopsy, intracranial biopsy, ventriculoperitoneal shunt, or major traumatic lesion within 28 days of study entry.
* Core needle biopsy (excluding intracranial biopsy) or other minor surgery within seven days of randomization. Placement of a central vascular access device (CVAD) if performed in the two days prior to bevacizumab administration
* History of abdominal fistula or gastrointestinal perforation within six months of study entry
* History of intracranial abscess within six months of randomization
* Any prior malignant neoplasm treated with curative intent in the five years prior to study entry, except for adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
* Patients with any other metabolic or psychological disease
* Hypersensitivity to products derived from Chinese hamster ovary cells or to other humanized or recombinant human antibodies

Primary outcomes:
measure: Progression-Free Survival (PFS) - Percentage of Participants With an Event
timeFrame: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks
measure: PFS - Time to Event
timeFrame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
measure: PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study
timeFrame: BL, 24 weeks (after 6th cycle)
Secondary outcomes:
measure: Overall Survival - Percentage of Participants With an Event
timeFrame: BL, every 28 days, until death or end-of-study, an average of 32 weeks
measure: Overall Survival - Time to Event
timeFrame: BL, every 28 days, until death or end-of-study, an average of 32 weeks
measure: Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
timeFrame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: