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GlioblastomaEarly Phase 1NCT01086345

Radiosurgery Plus Bevacizumab in Glioblastoma

A Early Phase 1 study testing radiosurgery, bevacizumab and irinotecan hydrochloride in people with Glioblastoma and Gliosarcoma, run by Case Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Gliosarcoma, Brain Tumor
What is being tested?
radiosurgery, bevacizumab and irinotecan hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Feb 2010to Dec 2014
Phase
Early Phase 1
Are there results?
None posted in the registry

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 proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV) at primary or subsequent resection
  • Radiographic evidence of tumor progression as defined by a contrast enhanced MRI at least 3 months after the completion of radiation therapy
  • Unifocal enhancing disease; the enhancing focus must be =< 3 cm in maximum diameter
  • History/physical examination within 14 days prior to registration
  • The patient must have recovered from the effects of prior therapy before study entry
  • The patient must not have received chemotherapy within the following time frames: Non-cytotoxic agents: 2 weeks, cytotoxic agents: 3 weeks, nitrosoureas: 6 weeks
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  • Must be able to undergo MRI imaging
  • Documentation of steroid doses within 14 days prior to registration
  • Karnofsky performance status > 60
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is acceptable)
  • BUN =< 30 mg/dl within 14 days prior to study entry
  • Creatinine =< 1.7 mg/dl within 14 days prior to study entry
  • Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg
  • Bilirubin =< 2.0 mg/dl within 14 days prior to study entry
  • ALT/AST =< 3 x normal range within 14 days prior to study entry
  • Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study entry
  • Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to study entry
  • Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria: 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 (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
  • Patients must provide study specific informed consent prior to study entry
  • Women of childbearing potential and male participants must practice adequate contraception
  • For females of child-bearing potential, negative serum pregnancy test within 14 days prior to entry

Who cannot join

  • Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years (for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
  • More than one focus of enhancement
  • Involvement of the brainstem (defined as the midbrain or lower)
  • Prior use of chemotherapy wafers or any other intratumoral or intracavitary treatment are not permitted; prior radiosurgery is not permitted
  • Prior treatment with intravenous bevacizumab
  • Unstable angina and/or congestive heart failure within the last 6 months
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  • Transmural myocardial infarction within the last 6 months
  • Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an EKG performed within 14 days of entry
  • New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
  • History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
  • Serious and inadequately controlled cardiac arrhythmia
  • Uncontrolled hypertension
  • Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for tumor resection
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of entry
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of entry
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
  • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol
  • Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
  • Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug
  • Patients treated on any other therapeutic clinical trials within 30 days prior to study entry or during participation in the study
  • Growth factors are not permitted to induce elevations in neutrophil count for the purposes of: 1) administration of temozolomide on the scheduled dosing interval; 2) allowing treatment with temozolomide at a higher dose; or 3) avoiding interruption of the treatment during concomitant radiotherapy
  • No other investigational drugs will be allowed during this study
  • Surgical procedures for tumor debulking, other types of chemotherapy, and immunotherapy or biologic therapy must not be used
  • Additional stereotactic boost radiotherapy is not allowed

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Phase I/II Trial of Radiosurgery Plus Bevacizumab in Patients With Recurrent/Progressive Glioblastoma

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. 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 glioblastoma by blocking blood flow to the tumor. Drugs used in chemotherapy such as irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiosurgery together with bevacizumab and irinotecan hydrochloride may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving radiosurgery together with bevacizumab and irinotecan hydrochloride works in treating patients with recurrent glioblastoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery

SECONDARY OBJECTIVES:

  1. To evaluate the toxicities of the combination of bevacizumab, irinotecan and radiosurgery.

II. To evaluate the progression-free survival of patients treated with bevacizumab, irinotecan and radiosurgery.

OUTLINE:

Patients receive bevacizumab IV over 30 minutes on days 1 and 15. Patients also receive irinotecan hydrochloride IV on days 1 and 15 beginning in course 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo radiosurgery 10-14 days after beginning bevacizumab.

After completion of study treatment, patients are followed for 18 months.

Being tested
radiosurgery, bevacizumab, irinotecan hydrochloride
Keywords
adult giant cell glioblastoma, adult gliosarcoma, recurrent adult brain tumor
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.

  • radiosurgeryRadiation

    Also called Radiation Surgery

    Patients undergo radiosurgery 10-14 days after beginning bevacizumab.

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, anti-VEGF rhuMAb, Avastin

    Given IV

  • irinotecan hydrochlorideDrug

    Also called Campto, Camptosar, camptothecin-11, CPT-11

    Given IV

Study groups in NCT01086345
Study groupRoleWhat they receive
Arm IExperimentalPatients receive bevacizumab IV over 30 minutes on days 1 and 15. Patients also receive irinotecan hydrochloride IV on days 1 and 15 beginning in course 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiosurgery 10-14 days after beginning bevacizumab.
Receives: Radiation: radiosurgery; Biological: bevacizumab; Drug: irinotecan hydrochloride

What is being measured

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

  1. Overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery

    Measured: Patients are followed for 18 months.

Secondary outcomes (2)

  1. Treatment-related toxicity

    Measured: Courses repeat every 28 days in the absence of unacceptable toxicity.

  2. Progression-free survival, defined as the interval from randomization to progression or death, whichever occurs first

    Measured: Patients are followed for 18 months.

Timeline

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

  1. First posted15 Mar 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionDec 2014
  4. Study completionDec 2014

Why it stopped: Slow Accrual

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01086345
Sponsor's protocol ID
CASE4309
Other IDs
NCI-2010-00309
Status last verified
Jun 2018
First submitted
11 Mar 2010
Last updated
3 Jul 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing radiosurgery, bevacizumab and irinotecan hydrochloride in people with Glioblastoma and Gliosarcoma, run by Case Comprehensive Cancer Center at 1 site 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 23 inclusion and 28 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: stopped early, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.

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?

Overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery (time frame: Patients are followed for 18 months.). 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 NCT01086345.

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 3 Jul 2018.

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