A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme

NCT00800917

Last updated date
Study Location
Rigshospitalet
Copenhagen, , , Denmark
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glioblastoma Multiforme
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme
Official Title  ICMJE A Phase II Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: Temsirolimus
    25 mg weekly IV
  • Drug: Bevacizumab
    10 mg/kg every 2 weeks
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2010)
12
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800917
Other Study ID Numbers  ICMJE BEV-CCI-779-GBM-02
Eudract no.: 2008-003679-40
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ulrik Lassen, MD, PH.D., Rigshospitalet
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE
  • University of Copenhagen
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Roche, Copenhagen
Investigators  ICMJE Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP