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Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM)

Randomized Phase II Trial of Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) In Adults With Recurrent Glioblastoma Multiforme

NCT01067469•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

The goal of this clinical research study is to learn if the combination of bevacizumab and lomustine can help to control glioblastoma. The safety of this combination will also be studied.

Detailed Description

The Study Drugs: Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Lomustine is designed to damage the DNA (genetic material of cells) of tumor cells, which may cause the tumor cells to die. Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group. * If you are in Group 1, you will receive a higher dose of bevacizumab. * If you are in Group 2, you will receive lomustine and a lower dose of bevacizumab Study Drug Administration: Each treatment cycle is 42 days. If you are in Group 1: On Days 1, 15, and 29 of every cycle, you will receive bevacizumab by vein over 90 minutes. If you are in Group 2: * On Days 1 and 22 of every cycle, you will receive bevacizumab by vein over 90 minutes. * On Day 3 of every cycle, you will take lomustine by mouth 1 time a day. You should take lomustine at bedtime 1 hour before or 2 hours after your last meal of the day with 1 cup (about 8 ounces) of water. Study Visits: If you are in Group 1 or 2, every 6 weeks: * You will be asked about any drugs you may be taking and if you have had any side effects. * You will have a physical exam, including measurement of your vital signs and weight. * You will have a neurological exam. * Your performance status will be recorded. * You will have an MRI scan. * If you are on anti-seizure drugs, blood (about 1 teaspoon) will be drawn to measure the amount of anti-seizure drugs in your blood. If you are in Group 1: * During Weeks 1-6, blood (about 3 teaspoons) drawn for routine tests 1 time a week. * After Week 6, blood (about 3 teaspoons) will be drawn for routine tests every 2 weeks. * On Weeks 2, 4, and 6, and then every 6 weeks after that, urine will be collected to check your kidney function. If you are in Group 2: * During Weeks 1-6, blood (about 3 teaspoons) drawn for routine tests 1 time a week. * After Week 6, blood (about 3 teaspoons) will be drawn for routine tests every 3 weeks. * On Weeks 3 and 6, and then every 6 weeks after that, urine will be collected to check your kidney function. Length of Study: You may stay on study treatment of lomustine and/or bevacizumab for up to 1 1/2 years. After that, you may continue taking bevacizumab for as long as the study doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse or you experience intolerable side effects. End of Study Treatment Visit: After you are off study treatment, you will have an end of study treatment visit. At this visit, you may have some or all of the following tests and procedures performed: * You will be asked about any drugs you may be taking and if you have had any side effects. * You will have physical exam, including measurement of your vital signs and weight. * Blood (about 3 teaspoons) will be drawn for routine tests. * You will have a neurological exam. * Your performance status will be recorded. Long-Term Follow-up: After the end of study treatment visit, the study staff will call you every 3 months to check how you are doing. Each phone call will take about 5 minutes. This is an investigational study. Bevacizumab and lomustine are FDA approved drugs and commercially available for the treatment of brain tumors. The use of these drugs in this combination is investigational. Up to 102 participants will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed Informed Consent Form
•2. Age \>/= 18 years
•4. Radiographic demonstration of disease progression following prior therapy
•5. Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on MRI performed within 14 days prior to registration (Day 1). Baseline MRIs for subjects who underwent salvage surgery after first or second relapse must be obtained \>/= 4 weeks after the procedure. If receiving corticosteroids, subjects must be on a stable or decreasing dose of corticosteroids for \>/= 5 days prior to baseline MRI.
•6. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: 1) They have recovered from the effects of surgery. 2) Evaluable or measurable disease following resection of recurrent tumor is not mandated for eligibility into the study. 3) To best assess the extent of residual measurable disease post-operatively, a MRI should be done no later than 96 hours in the immediate post-operative period or 4-6 weeks post-operatively. .
•7. An interval of \>/= 4 weeks since surgical resection is required prior to starting protocol therapy.
•8. Prior standard radiation for glioblastoma
•9. Prior chemotherapy: All first-relapse subjects must have received temozolomide. All second- and third-relapse subjects must have received temozolomide. Patients may not have received prior nitrosoureas.
•10. Recovery from the effects of prior therapy, including the following: Four weeks from cytotoxic agents (3 weeks from procarbazine, 2 weeks from vincristine); Four weeks from any investigational agent; One week from non-cytotoxic agents(eg accutane, thalidomide); Eight weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field; Patients may have had gliadel wafers during their original surgery but they must be \>/= 9 months post their original surgery date.
•11. Prior therapy with gamma knife or other focal high-dose radiation is allowed, but the subject must have subsequent histologic documentation of recurrence or positron emission tomography (PET) or MR Spectroscopic documentation of tumor, unless the recurrence is a new lesion outside the irradiated field
+8 more criteria

Exclusion Criteria

•1. Prior treatment with anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) agent or nitrosurea (eg. lomustine, carmustine, nimustine).
•2. Prior treatment with polifeprosan 20 with carmustine wafer except for the patients with gliadel wafers \>/= 9 months post their original surgery date.
•3. Patients must not have received any investigational agents within 28 days prior to commencing study treatment.
•4. Prior intracerebral agents
•5. Need for urgent palliative intervention for primary disease (e.g., impending herniation)
•6. Evidence of recent hemorrhage on baseline MRI of the brain with the following exceptions: (1) Presence of hemosiderin (2) Resolving hemorrhagic changes related to surgery (3) Presence of punctate hemorrhage in the tumor
•7. Blood pressure of \> 140 mmHg systolic and \> 90 mmHg diastolic
•8. History of hypertensive encephalopathy
•9. New York Heart Association (NYHA) Grade II or greater chronic heart failure(CHF)
•10. History of myocardial infarction or unstable angina within 6 months prior to Day 1
+15 more criteria

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

October 1, 2016

Completion Date

October 1, 2016

Last Updated

March 17, 2020

Enrollment

ACTUAL participants

Conditions

Brain CancerGlioblastoma

Interventions

Standard Dose Bevacizumab

DRUG

Low Dose Bevacizumab

DRUG

Lomustine

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM)

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

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