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Adult GlioblastomaPhase 2NCT00433381

Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma

A Phase 2 study testing Bevacizumab, Irinotecan Hydrochloride and Temozolomide in people with Adult Glioblastoma and Adult Gliosarcoma, run by National Cancer Institute (NCI) at 93 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase II trial is studying the side effects and how well giving bevacizumab together with irinotecan or temozolomide works in treating patients with recurrent or refractory glioblastoma multiforme or gliosarcoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Irinotecan Hydrochloride and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
93 sitesUnited States
Study dates
1 Mar 2007to 16 Feb 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma
  • Original histology of low-grade glioma with subsequent histological diagnosis of GBM or gliosarcoma allowed
  • Recurrent or refractory disease, meeting all of the following criteria:
  • Must have received prior temozolomide
  • Pathologic or imaging confirmation of tumor progression or regrowth required
  • Confirmation of true progressive disease (rather than radiation necrosis) by positron emission tomography, thallium scanning, MRI spectroscopy, or surgical documentation required for patients who received prior interstitial brachytherapy, Gliadel wafer, or stereotactic radiosurgery
Show all 66Show fewer
  • Unequivocal radiographic evidence of tumor progression by MRI within the past 14 days (while on a stable dose of steroids for ? 5 days)
  • No acute intratumoral hemorrhage on MRI
  • Patients with MRI demonstrating old hemorrhage or subacute blood after a neurosurgical procedure (biopsy or resection) are eligible
  • Karnofsky performance status 70-100%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after completion of bevacizumab therapy
  • Systolic blood pressure ? 160 mm Hg or diastolic blood pressure ? 90 mm Hg (antihypertensive medication allowed)
  • Able to undergo brain MRI scans with intravenous gadolinium
  • Absolute neutrophil count ? 1,500 cells/mm?
  • Platelet count ? 100,000 cells/mm?
  • Hemoglobin ? 10 g/dL (transfusion or other intervention allowed)
  • WBC ? 3,000 cells/mm?
  • AST < 2 times upper limit of normal
  • Bilirubin ? 1.6 mg/dL
  • Creatinine < 1.5 mg/dL
  • Urine protein:creatinine ratio ? 0.5 by urinalysis OR total urinary protein < 1,000 mg by 24-hour urine collection
  • INR < 1.4 (for patients not on warfarin)
  • No patients with severely impaired renal function (i.e., estimated glomerular filtration rate < 30 mL/min or on dialysis)
  • No other prior invasive malignancy, except nonmelanomatous skin cancer or carcinoma in situ of the cervix, unless the patient has been disease free and off therapy for that disease for ? 3 years
  • No severe, active comorbidity, defined as any of the following:
  • Transmural myocardial infarction or unstable angina within the past 6 months
  • Evidence of recent myocardial infarction or ischemia manifested as ST elevation of ? 2 mm by EKG performed within the past 14 days
  • New York Heart Association class II-IV congestive heart failure requiring hospitalization within the past 12 months
  • History of stroke or transient ischemic attack within the past 6 months
  • Cerebrovascular accident within the past 6 months
  • Serious and inadequately controlled cardiac arrhythmia
  • Significant vascular disease (e.g., aortic aneurysm or history of aortic dissection)
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Serious or nonhealing wound, ulcer, or bone fracture
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 14 days
  • Acquired immune deficiency syndrome (AIDS)
  • No significant traumatic injury within the past 28 days
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No condition that impairs the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication; requirement for IV alimentation; prior surgical procedures affecting absorption; or active peptic ulcer disease)
  • No disease that would obscure toxicity or dangerously alter drug metabolism
  • No concurrent major surgical procedures
  • Recovered from prior therapy
  • Recent resection of recurrent or progressive tumor allowed provided the following criteria are met:
  • Failed prior radiotherapy that was completed ? 42 days ago
  • Residual disease after resection of recurrent glioblastoma is not mandated
  • More than 28 days since prior surgery or open biopsy
  • More than 7 days since prior core or needle biopsy
  • At least 28 days since prior investigational agents
  • At least 14 days since prior vincristine
  • At least 42 days since prior nitrosoureas
  • At least 21 days since prior procarbazine
  • At least 28 days since other prior cytotoxic therapy
  • At least 7 days since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin [except radiosensitizers])
  • At least 14 days since prior enzyme-inducing antiepileptic drugs (EIAEDs)
  • Concurrent non-hepatic EIAEDs allowed
  • No other concurrent CYP3A4 inducers, such as rifampin or Hypericum perforatum (St. John's wort)
  • Concurrent full-dose anticoagulants (e.g., warfarin or low molecular weight heparin) allowed provided all of the following criteria are met:
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulants or on a stable dose of low molecular weight heparin
  • No concurrent highly active antiretroviral therapy
  • No concurrent prophylactic use of growth factors

Who cannot join

None listed.

Trial locations and contacts

93 sites in 1 country.

93 sites in 1 country

United States93 sites

  • Akron General Medical Center

    Akron, Ohio, 44307

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45420

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • John F Kennedy Medical Center

    Edison, New Jersey, 08818

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Marin General Hospital

    Greenbrae, California, 94904

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Cheshire Medical Center-Dartmouth-Hitchcock Keene

    Keene, New Hampshire, 03431

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • EvergreenHealth Medical Center

    Kirkland, Washington, 98033

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Yale University

    New Haven, Connecticut, 06520

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Sutter Cancer Research Consortium

    Novato, California, 94945

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Radiation Therapy Oncology Group

    Philadelphia, Pennsylvania, 19103

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Adventist Medical Center

    Portland, Oregon, 97216

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Reid Health

    Richmond, Indiana, 47374

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Norris Cotton Cancer Center-North

    Saint Johnsbury, Vermont, 05819

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Intermountain Health Care

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • Arizona Oncology Services Foundation

    Scottsdale, Arizona, 85260

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Bevacizumab With Irinotecan or Bevacizumab With Temozolomide in Recurrent Glioblastoma

This randomized phase II trial is studying the side effects and how well giving bevacizumab together with irinotecan or temozolomide works in treating patients with recurrent or refractory glioblastoma multiforme or gliosarcoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan or temozolomide may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the efficacy of bevacizumab and irinotecan hydrochloride, in terms of 6-month progression-free survival rate, in patients with recurrent or refractory intracranial glioblastoma multiforme or gliosarcoma.

II. Determine the adverse event profile and tolerability of bevacizumab and temozolomide in these patients.

SECONDARY OBJECTIVES:

  1. Determine the efficacy of bevacizumab and temozolomide, in terms of 6-month progression-free survival rate, in patients previously treated with temozolomide.

II. Determine the efficacy of bevacizumab and irinotecan hydrochloride, in terms of objective response, in patients with measurable disease.

III. Determine the efficacy of bevacizumab and temozolomide, in terms of objective response, in patients with measurable disease who were previously treated with temozolomide.

IV. Determine the toxicity profile and tolerability of bevacizumab and irinotecan hydrochloride in these patients.

TERTIARY OBJECTIVES:

  1. Assess the potential role of perfusion MRI and magnetic resonance spectroscopy imaging as an early indicator of response to therapy after 2 weeks of treatment with bevacizumab.

II. Assess the potential role of perfusion MRI and magnetic resonance spectroscopy imaging as a prognostic indicator based on images taken at baseline, at 2 weeks, and after 2 courses of study treatment.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (< 50 vs >= 50 years of age) and Karnofsky performance status (70-80% vs 90-100%). Patients are randomized to 1 of 2 treatment arms with a 2:1 ratio (arm I:arm II).

ARM I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21.

ARM II: Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15.

In both arms, treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. All patients undergo MRI at baseline and at every 2 courses (no 2-week MRI) per standard of care until progression or discontinuation of treatment to assess areas of breakdown of the blood-brain barrier. Patients undergo an additional MRI after study therapy. Consenting patients also undergo diffusion and perfusion MRI and magnetic resonance spectroscopic imaging for correlative studies.

After completion of study therapy, patients are followed up for at least 1 month.

Medical subject headings
Glioblastoma, Gliosarcoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • Irinotecan HydrochlorideDrug

    Also called Campto, Camptosar, Camptothecin 11, Camptothecin-11

    Given IV

  • TemozolomideDrug

    Also called CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831

    Given orally

Study groups in NCT00433381
Study groupRoleWhat they receive
Arm I (bevacizumab and temozolomide)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21.
Receives: Biological: Bevacizumab; Drug: Temozolomide
Arm II (bevacizumab & irinotecan hydrochloride)ExperimentalPatients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15.
Receives: Biological: Bevacizumab; Drug: Irinotecan Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Irinotecan Hydrochloride Arm

    Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.

    Measured: From randomization to six months.

  2. Count/Percentage of Patients Discontinuing Treatment Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm)

    This endpoint determines tolerability of this treatment arm. If tolerable, then the secondary endpoint of treatment efficacy for this arm occurs. Percentage is calculated by taking the number of patients who did not stop bevacizumab and temozolomide treatment due to medical complications in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who did not begin treatment.

    Measured: From randomization to end of treatment (treatment can continue up to 24 months for patients with stable or responding tumor).

  3. Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6)

    Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 6-month progression-free survival (PFS-6) over all study participants. Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to progression, evaluated at 96wks, is the determinate of PFS at 6months (PFS-6). Subjects will not be analyzed by arm.

    Measured: 2 and 8 weeks posttreatment, and every 2 months until 96wks

  4. Number of Participants With Predicted Overall Survival (OS) at 12 Months

    Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 12-month overall survival (OS).

    Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to death, evaluated at 96wks, is the determinate of OS at 12 months. Subjects will not be analyzed by arm.

    Measured: 2 and 8 weeks posttreatment, and every 2 months until 96wks

Secondary outcomes (10)

  1. Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Temozolomide Arm

    Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.

    Measured: From randomization to six months.

  2. Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression)

    Tumor size measured in millimeters and is the largest crosssectional area using perpendicular measurements of contrast enhancing abnormality. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off corticosteroids, and neurologically stable or improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive MRI scans at least 1 month apart, corticosteroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Stable disease (SD): Does not qualify for CR, PR, or PD.

    Measured: From randomization to death or last follow-up. Patients were followed up to 62.9 months.

  3. Agreement Between Local Interpretation and Central Interpretation of Standard MRI

    Local and central interpretations of the standard MRI were assessed for progression and survival at all available imaging (baseline visit, week 2, and after every 2 cycles of treatment, and at termination of treatment). Patients who suffer clinical progression without radiographic confirmation of progression were considered to have progressive disease in determination of PFS-6. Subjects participated in the MR substudies regardless of therapeutic intervention

    Measured: baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment

  4. Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard

    Local reads were treated as the test and central reads were treated as the reference standard. Thus, a participant meeting the definition of progression on any standard MRI central interpretation (baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment) was considered positive for PFS-6. Therefore, a true positive is defined as a positive local interpretation for a subject with a positive central read.

    Measured: baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment

  5. Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to N-acetylaspartate (NAA) (Lac/NAA) Ratio

    Aim not included in final (February 10, 2009) protocol (removed from section 2).

    Measured: 2 weeks following initiation of protocol treatment (T1) and at 8 weeks following chemotherapy with bevacizumab (T2)

  6. Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to Patient Response

    Aim not included in final (February 10, 2009) protocol (removed from section 2)

    Measured: 2 weeks following initiation of protocol treatment (T1)

  7. Predictive Value of CBV and Lac/NAA in Assessing 6-month Progression-free Survival

    Aim not included in final (February 10, 2009) protocol (removed from section 2)

    Measured: 2 weeks following initiation of protocol treatment (T1)

  8. Change in Perfusion MRI Markers at Week 2 as Predictors of 12mo Overall Survival (OS)

    To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 2 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 2 are the prognostic indicators.

    Measured: Baseline and 2 Weeks

  9. Change in Perfusion MRI Markers at Week 8 as Predictors of 12mo Overall Survival (OS)

    To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 8 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 8 are the prognostic indicators.

    Measured: Baseline and 8 weeks

  10. Change in Perfusion MRI Markers at Week 16 as Predictors of 12mo Overall Survival (OS)

    To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 16 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 16 are the prognostic indicators.

    Measured: Baseline and 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2007 (estimated)
  2. Study start1 Mar 2007
  3. Primary completion21 Jan 2010
  4. Study completion16 Feb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00433381
Sponsor's protocol ID
NCI-2009-00743
Other IDs
NCI-2009-00743, RTOG-0625, ACRIN-6677, CDR0000528259, RTOG 0625, RTOG-0625, U10CA021661
Status last verified
Aug 2018
First submitted
8 Feb 2007
Last updated
17 Sep 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Irinotecan Hydrochloride and Temozolomide in people with Adult Glioblastoma and Adult Gliosarcoma, run by National Cancer Institute (NCI) at 93 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 66 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Irinotecan Hydrochloride Arm (time frame: From randomization to six months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00433381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.

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