A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01115491
First received: April 30, 2010
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Glioblastoma Multiforme
Drug: bevacizumab [Avastin]
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival (PFS) at 6 months (24 weeks) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab [Avastin]
Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks
Drug: temozolomide
Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115491

Locations
Spain
Barcelona, Spain, 08907
Barcelona, Spain, 08916
Barcelona, Spain, 08025
Madrid, Spain, 28041
Madrid, Spain, 28040
Madrid, Spain, 28046
Valencia, Spain, 46026
Valencia, Spain, 41014
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01115491     History of Changes
Other Study ID Numbers: ML25152, 2010-019051-21
Study First Received: April 30, 2010
Last Updated: October 7, 2013
Health Authority: Spain: Agencia Española del medicamento y productos sanitarios.

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Bevacizumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014