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Brain and Central Nervous System TumorsPhase 2NCT00998010

Bortezomib, Temozolomide, and Regional Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

A Phase 2 study testing bortezomib + temozolomide+ radiation therapy in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

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

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
bortezomib + temozolomide+ radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
3 Oct 2011to 20 Apr 2018
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

  • Must be >- 18 years old, with a life expectancy > 8 weeks
  • Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma
  • Must submit an unstained paraffin block or slides from surgical procedure
  • Patients without prior treatment and with prior diagnosis of lower-grade gliomas that have been upgraded to GBM after repeated resection allowed
  • At least 21 days since cranial MRI or contrast CT scan OR ≥ 96 hours since cranial MRI or contrast CT scan for patients who underwent surgical resection
  • Measurable or assessable disease
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  • Voluntary written informed consent obtained before performance of any study related procedure not part of normal medical care.
  • Karnofsky performance status > 60%
  • White Blood Count (WBC) ≥ 3,000/mm^3
  • absoulte neutrophil count(ANC) ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL (transfusion allowed)
  • Bilirubin < 2.5 times upper limit of normal (ULN)
  • serum glutamic-oxaloacetic transaminase (SGOT) < 2.5 times ULN
  • Creatinine < 1.5 mg/dL
  • Creatinine clearance ≥ 20 mL/minute
  • Serum sodium > 130 mmol/L
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Patients on Enzyme-Inducing Antiepileptic Drugs (EIAED) must be transitioned to non- EAIED for ≥ 2 weeks
  • Concurrent full-dose warfarin or its equivalent (e.g., unfractionated and/or low molecular weight heparin) allowed

Who cannot join

  • peripheral neuropathy ≥ grade 2
  • Myocardial infarction within the past 6 months
  • New York Heart Association (NYHA) class III or IV heart failure
  • Uncontrolled angina
  • Severe uncontrolled ventricular arrhythmias
  • Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
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  • hypersensitivity to bortezomib, boron, or mannitol
  • serious medical or psychiatric illness that would interfere with study participation including, but not limited to, any of the following:
  • Ongoing or active infection requiring IV antibiotics
  • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • Disorders associated with a significant immunocompromised state (e.g., HIV, systemic lupus erythematosus)
  • history of stroke within the past 6 months
  • other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy (i.e., cervical cancer), or low-risk prostate cancer after curative therapy
  • significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
  • disease that will obscure toxicity or dangerously alter drug metabolism
  • viral hepatitis (HBV surface antigen positive) or active hepatitis C infection
  • Prior or concurrent corticosteroids, automated external defibrillator, analgesics, and other drugs to treat symptoms or prevent complications allowed
  • concurrent investigational drugs that must be stopped at least 4 months prior to therapy.
  • prior radiotherapy to the brain
  • prior cytotoxic or noncytotoxic drug therapy or experimental drug therapy (including chemotherapy, hormonal therapy, or immunotherapy) directed against the brain tumor
  • prior polifeprosan 20 with carmustine implant (Gliadel wafer)
  • concurrent stereotactic radiosurgery or brachytherapy
  • concurrent sargramostim
  • concurrent inducers of CYP450 3A4 (e.g., enzyme-inducing anti-epileptic drugs [EIAED])

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Phase II Trial of Velcade (Bortezomib) in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bortezomib together with temozolomide and radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

PURPOSE: This phase II trial is studying the side effects and how well bortezomib works when given together with temozolomide and regional radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.

Read the detailed description

OBJECTIVES:

Primary

  • Estimate the overall survival at 2 years of patients with newly diagnosed glioblastoma multiforme treated with bortezomib in combination with temozolomide and regional radiotherapy followed by maintenance therapy comprising bortezomib and temozolomide.

Secondary

  • Investigate further the safety and tolerability of this regimen in these patients.
  • Determine the molecular characterization of tumor tissue and correlate these findings with response.

OUTLINE: This is a multicenter study.

  • Adjuvant chemotherapy: Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42. Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Maintenance: Beginning 2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected at baseline (from surgery) and periodically during study for further analysis.

After completion of study therapy, patients are followed up periodically.

Being tested
bortezomib + temozolomide+ radiation therapy
Keywords
adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

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

  • bortezomib + temozolomide+ radiation therapyDrug

    Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200 centigray (cGy) daily doses to a total dose of 6000 cGy.

Study groups in NCT00998010
Study groupRoleWhat they receive
ExperimentalExperimentalPatients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: bortezomib + temozolomide+ radiation therapy

What is being measured

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

  1. Overall Survival

    Estimate the overall survival in subjects with newly-diagnosed glioblastoma (GBM) treated with bortezomib/temozolomide/radiation followed by bortezomib/temozolomide for 24 cycles until progression is detected or for up to 24 cycles (~2 years).

    Measured: 2 years

Secondary outcomes (4)

  1. Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.

    Measured: 2 years

  2. Time to Progression

    Median time to tumor progression. Because many newly-diagnosed patients are likely not to have evaluable disease due to gross total resections. A 7-point scale was used to guide Magnetic resonance imaging (MRI) assessment to determine progression in this study. A -2 or -3 assessment will be taken as progression.

    The 7-point scale is listed below. complete resolution of tumor: 3 tumor definitely smaller: 2 tumor probably smaller: 1 tumor unchanged: 0 tumor probably worse: -1 tumor definitely worse: -2 new lesion: -3

    Measured: From the completion of radiation treatment to tumor progression

  3. Survival at 1 Year

    Overall Survival at 12 months from completion of radiation treatment

    Measured: 1 year

  4. Tumor Progression as Assessed by Magnetic Resonance Imaging (MRI) and Neurologic Exam

    MRI will be done 2 weeks after completion of radiation and then every 8 weeks. Neurologic exam to be performed every 2 weeks during radiation therapy, then every every 4 weeks after radiation is completed.

    Measured: at 6, 12, 18 and 24 months from completion of radiation treatment.

Timeline

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

  1. First posted20 Oct 2009 (estimated)
  2. Study start3 Oct 2011
  3. Primary completion29 Mar 2016
  4. Study completion20 Apr 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00998010
Sponsor's protocol ID
11-002222
Other IDs
UCLA-X05303, CDR0000657015, MILLENNIUM-UCLA-X05303, 09-03-084
Status last verified
May 2019
First submitted
17 Oct 2009
Last updated
28 Aug 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib + temozolomide+ radiation therapy in people with Brain and Central Nervous System Tumors, run by Jonsson 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 21 inclusion and 24 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 28 Aug 2020. 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?

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 17 Jul 2020). 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?

Overall Survival (time frame: 2 years). 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 NCT00998010.

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 28 Aug 2020.

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