GlioblastomaPhase 2NCT00921167

A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas

A Phase 2 study testing Bevacizumab/Irinotecan in people with Glioblastoma and Astrocytoma, run by Clinical Research Center for Solid Tumor, Korea at 1 site in South Korea.

Completed

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

Official record

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Trial summary

To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioblastoma, Astrocytoma
What is being tested?: Bevacizumab/Irinotecan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteSouth Korea
Study dates: Jun 2009to Dec 2013
Phase: Phase 2
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 diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme
At least 18 years of age
Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria
One or more measurable disease
Adequate hematologic (neutrophil count >= 1500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit (UNL)x2.5, bilirubin level =< UNLx1.5, alkaline phosphatase =< UNLx2.5), and renal (creatinine clearance >= 30mL/min)
Expected life time more than at least 2 months
A patients who signed the informed consent prior to the participation in the study

Who cannot join

A pregnant or lactating patient
A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease
Uncontrolled serious infection

Show all 9Show fewer

Enrollment in other study within 30 days
Hemorrhage on baseline radiologic examination
A patient who refused to sign the informed consent

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme

To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme

Conditions: Glioblastoma, Astrocytoma
Being tested: Bevacizumab/Irinotecan
Keywords: Glioblastoma, Astrocytoma, Chemotherapy
Medical subject headings: Glioblastoma, Astrocytoma

What participants receive

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

Bevacizumab/IrinotecanDrug
Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs [EIAEDs] or 340mg/m2 for patients on EIAEDs) every 2 weeks

Study groups in NCT00921167
Study group	Role	What they receive
Bevacizumab/Irinotecan	Experimental	Not described Receives: Drug: Bevacizumab/Irinotecan

What is being measured

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

Progression-free survival
Measured: 6 months, 1 year

Secondary outcomes (4)

Objective response rate
Measured: 6 weeks, 12 weeks
Overall survival
Measured: 6 months, 1 year
Disease-control rate
Measured: 6 weeks, 12 weeks
Adverse event
Measured: 3 weeks, 6 weeks, 9 weeks, 12 weeks

Timeline

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

Jun 2009Dec 2013

First posted16 Jun 2009 (estimated)
Study startJun 2009
Primary completionJun 2012
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GlioblastomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00921167
Sponsor's protocol ID: CRCST-L-0006
Status last verified: Dec 2013
First submitted: 13 Jun 2009
Last updated: 4 Dec 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
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PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

All Glioblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme
ClinicalTrials.gov ID: NCT00921167
Acronym / sponsor ID: CRCST-L-0006
Conditions: Glioblastoma, Astrocytoma
Keywords: Glioblastoma, Astrocytoma, Chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (estimated)
Lead sponsor: Clinical Research Center for Solid Tumor, KoreaUniversity, hospital or other
Collaborators: Seoul National University Hospital
Study start: Jun 2009
Primary completion: Jun 2012 (actual)
Study completion: Dec 2013 (actual)
First posted: 16 Jun 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bevacizumab/Irinotecan	Experimental	Drug: Bevacizumab/Irinotecan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Histologically diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme
At least 18 years of age
Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria
One or more measurable disease
Adequate hematologic (neutrophil count >= 1500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit (UNL)x2.5, bilirubin level =< UNLx1.5, alkaline phosphatase =< UNLx2.5), and renal (creatinine clearance >= 30mL/min)

Key exclusion criteria (9 listed)

A pregnant or lactating patient
A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bevacizumab/IrinotecanBevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs [EIAEDs] or 340mg/m2 for patients on EIAEDs) every 2 weeks	Drug	Bevacizumab/Irinotecan

Primary outcome

Progression-free survival
Time frame: 6 months, 1 year

4 secondary outcomes

Objective response rate
Time frame: 6 weeks, 12 weeks
Overall survival
Time frame: 6 months, 1 year
Disease-control rate
Time frame: 6 weeks, 12 weeks
Adverse event
Time frame: 3 weeks, 6 weeks, 9 weeks, 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.

Related trials for Glioblastoma

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab/Irinotecan in people with Glioblastoma and Astrocytoma, run by Clinical Research Center for Solid Tumor, Korea at 1 site in South Korea.

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 7 inclusion and 9 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 4 Dec 2013. 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 South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free survival (time frame: 6 months, 1 year). 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 NCT00921167.

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 4 Dec 2013.