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A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme

Study Purpose

This trial is an investigator initiated, open label phase II study, where patient with recurrent primary GBM will be considered for the study. Only patients with recurrence after Temozolomide and VEGF-directed therapy with Bevacizumab will be considered for the study. Patients will receive temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15 and 22 and bevacizumab 10 mg/kg IV over 30-90 minutes on day 8 and 22. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. A safety analysis will be performed when the first 10 patients have received minimum 4 cycles (8 weeks). The study will then be stopped: If DLT is observed in > 2/10 patients, Occurrence of any serious adverse events not described in the SPC of each agents, If partial remission is not observed in at least 1/10 patients

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Written informed consent.
  • - Histological verification of primary GBM and failure after radiotherapy and temozolomide (TMZ) - Previously treated with VEGF-directed therapy with bevacizumab.
  • - Previously received radiotherapy and temozolomide.
  • - More than 4 weeks since any of the following prior treatments: chemotherapy (6 weeks for nitrosoureas or mitomycin C) - Radiotherapy to nontarget lesions or lesions that are not to be biopsied VEGF-directed therapy (including bevacizumab) - Investigational agents.
  • - More than 6 months since prior major surgery or open biopsy and recovered (only 6 weeks required if operation is for recurrent GBM) - No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of the following: - Temsirolimus.
  • - Bevacizumab.
  • - CYP450 isoenzymes.
  • - ECOG performance status 0-1.
  • - WBC ≥ 3,000 mm³ - Absolute neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Bilirubin and phosphate normal.
  • - AST and ALT ≤ 2.5 times upper limit of normal.
  • - Creatinine normal OR creatinine clearance ≥ 60 mL/min.
  • - Urine protein: creatinine ratio < 1.0 OR 24-hour urine protein < 1,000 mg.
  • - Fasting cholesterol < 350 mg/dL (cholesterol medications are allowed) - Fasting triglycerides < 400 mg/dL.
  • - PT INR ≤ 1.5.
  • - Hematocrit < 41% (for males) or < 38% (for females) - Fertile females must use an approved contraceptive (p-pills, IUD, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal depot plaster), throughout the study and 3 months after discontinuation of study drugs.
Fertile men must use dobbelt barrier method (preservative with sperm inhibiting creme) or female partner uses the above mentioned contraceptive.
  • - Fertile males must use preservatives.

Exclusion Criteria:

  • - Clinically significant cardiovascular disease, including the following: - Cerebrovascular accident within the past 6 months.
  • - Transient ischemic attack within the past 6 months.
  • - Myocardial ischemia within the past 6 months.
  • - Myocardial infarction within the past 6 months.
  • - Other thromboembolic event within the past 6 months.
  • - Unstable angina within the past 6 months.
  • - Uncontrolled hypertension (i.e., hypertension despite maximal therapy) - New York Heart Association class II-IV heart disease.
  • - Congestive heart failure.
  • - Serious cardiac arrhythmia requiring medication.
  • - Clinically significant peripheral vascular disease.
  • - Uncontrolled intercurrent illness.
  • - Ongoing or active infection.
  • - One of the following within the past 6 months.
  • - Abdominal fistula.
  • - Gastrointestinal perforation.
  • - Intra-abdominal abscess.
  • - Serious or nonhealing wound, ulcer, or bone fracture.
  • - Psychiatric illness or social situations that would preclude study compliance.
  • - Uncontrolled diabetes.
  • - Hemoglobin A1c > 7% - Concurrent non-study related surgical procedures.
  • - Concurrent treatment with CYP3A4 inducers or inhibitors.
  • - Other concurrent anticancer agents or therapies.
  • - Significant traumatic injury within the past 28 days.
  • - History of allergic reactions to compounds of similar chemical or biological composition to temsirolimus or bevacizumab.
  • - Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (e.g., infliximab) - Pregnancy or nursing.
  • - Patients previously intolerant to bevacizumab.
- Anticoagulant therapy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00800917
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Rigshospitalet, Denmark
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Completed
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rigshospitalet, Copenhagen, Denmark

Status

Address

Rigshospitalet

Copenhagen, ,

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