Bevacizumab in Pats w/ Recurrent ST Brain Metas Who Have Failed Whole Brain Radiation Therapy

NCT01898130 | Completed Phase 2 Results DMC

• 3 other identifiers: NU 12C06NCI-2013-00448STU00080404
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

This is a study to evaluate a drug called bevacizumab in patients with cancer whose disease has spread to their brain. This study will not evaluate the effect of bevacizumab on the systemic solid tumor cancer. Bevacizumab is a medication and it is thought that bevacizumab may interfere with the growth of new blood vessels; therefore it might stop tumor growth and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Objective Radiographic Tumor Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab

  Radiographic Response to treatment will be assessed prior to every odd-numbered cycle using CT or MRI scans until disease progression, unacceptable toxicity as assessed by the Response Assessment in Neuro-Oncology (RANO) Criteria for target lesions. Response is defined as the number of patients with Complete Response (CR) plus those with Partial Response (PR) radiographically. Generally CR is defined as the disappearance of all target lesions and PR is defined as \>=50% decrease in the sum of the longest diameter of target lesions.

  Every other cycle, starting cycle 3 (1 cycle =28 days) until off study. Range of cycles completed 1-20.

Secondary Outcomes (7)

• Progression-Free Survival (PFS) at 6 Months in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab

  At 6 months from treatment initiation.

• Time to Progression in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab

  From treatment initiation, every 2 cycles (1 cycle = 28 days) until progressive disease. Range of cycles completed 1-20.

• Time to Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab

  From the start of treatment every 2 cycles (1 cycle =28 days) until time of response. Range of cycles completed 1-20.

• Duration of Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab

  From documentation of response, every two cycles (1 cycle =28 days) until progressive disease. Range of cycles completed 1-20.

• Overall Survival (OS) in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab

  From start of treatment until death from any cause. Median follow up of 8 months (range 1.3 to 47.9 months)

Study Arms (1)

Treatment (bevacizumab)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: bevacizumab; Procedure: quality-of-life assessment

Interventions

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Treatment (bevacizumab)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (bevacizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically or cytologically confirmed non-central nervous system (CNS) primary solid malignancy at the time of initial diagnosis; NOTE: brain lesions are not required to have pathologic confirmation; in addition, a copy of the pathology report for the primary tumor is sufficient for registration purposes
• Patients must have radiographically-confirmed recurrent brain metastases from a solid tumor after WBRT
• Patients must have measurable or evaluable disease in the brain
• Patients must have been on a stable dose of corticosteroids \>= 5 days prior to obtaining their baseline gadolinium (Gd)-MRI of brain
• Patients must have completed WBRT \> 12 weeks prior to enrollment to limit cases of pseudoprogression; however if new lesions are noted \< 12 weeks but \> 4 weeks prior to enrollment, those patients are eligible
• Patients who underwent radiosurgery to treat a progressive lesion must have confirmation of tumor by tissue, magnetic resonance spectroscopy (MRS), magnetic resonance (MR) perfusion or positron emission tomography (PET) and the lesion must be measurable; NOTE: radiosurgery may be done to a lesion that will not be used for response evaluation and should be done \> 2 weeks prior to enrollment
• Patients may be on other systemic chemotherapies if progressive CNS disease occurs while on these treatments; NOTE: new systemic chemotherapies should not be started unless required to treat systemic disease and should not start until at least 1 follow up imaging study has been performed
• Patients may have received any number of prior CNS directed therapies - there are no limitations
• Patients must have a life expectancy of \>= 12 weeks
• Patients must have a Karnofsky performance score (KPS) of \>= 60
• Whole blood cell (WBC) \>= 3,000/ul
• Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• Platelets \>= 100,000/mm\^3
• Hemoglobin \>= 10 gm/dl (may be reached by transfusion)
• Serum glutamic oxaloacetic transaminase (SGOT) \< 2 x upper limit of normal (ULN) (or \< 5 x ULN if liver is involved)

You may not qualify if:

• Patients with a diagnosis of intrathoracic lung carcinoma of squamous cell histology are not eligible for participation
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using barrier birth control methods, are not eligible for participation
• Patients must not have baseline proteinuria within 14 days prior to registration as demonstrated by either:
• Urine protein: creatinine (UPC) ratio \< 1.0 at screening, OR
• Urine dipstick for proteinuria =\< 2+; NOTE: patients discovered to have \>= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =\< 1g of protein in 24 hours to be eligible
• Patients must not have experienced any major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, or be anticipated to need a major surgical procedure during the course of the study; NOTE: the exception is craniotomy
• Patients must not have experienced a core biopsy or other minor surgical procedure within 7 days prior to registration; NOTE: this excludes placement of a vascular access device
• Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the previous 6 months are not eligible for participation
• Patients with a serious, non-healing wound, ulcer, or bone fracture are not eligible for participation due to the effects on vasculature by bevacizumab which may impair healing
• Patients known to be human immunodeficiency virus (HIV) or hepatitis B and/or C positive are not eligible for participation; NOTE: HIV and hepatitis testing is not required for study participation
• Patients with a history of any other cancer (except for non-melanoma skin cancer or carcinoma in-situ of the cervix), are not eligible for participation unless they are in complete remission and have been off of all therapy for that disease for a minimum of 3 years
• Patients receiving or participating on any other experimental agents/clinical trials are not eligible for participation
• Patients with a known hypersensitivity to any component of bevacizumab are not eligible for participation
• Patients with any significant medical illnesses or infection that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy are not eligible for participation
• Patients with leptomeningeal disease are not eligible for participation

Sponsors & Collaborators

• Northwestern University: lead
• Genentech, Inc.: collaborator

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital: Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Cadence Health - CDH

Warrenville, Illinois, 60555, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Priya Kumthekar, MD
• Organization: Northwestern University

p-kumthekar@northwestern.edu

312-503-1818

Study Officials

• Priya Kumthekar

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 12, 2013
• Study Start: November 27, 2013
• Primary Completion: March 23, 2017
• Study Completion: September 5, 2018
• Last Updated: September 17, 2019
• Results First Posted: April 25, 2019

Record last verified: 2019-03

Locations

US (4)