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

Completed · Phase 2

Conditions studied: Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT01898130

Run by

Northwestern University

People needed

27

Starts

2013-11-27

Expected to finish

2018-09-05

Last updated by the study team

2019-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• Bilirubin < 2 x ULN (or < 5 x ULN if liver is involved)
• Creatinine < 1.5 x ULN
• Patients of both sexes must agree to the use of barrier contraceptives throughout the duration of treatment on this trial and for 3 months after discontinuing treatment; NOTE: hormonal contraceptives are not acceptable as a sole method of contraception
• Patients must be > 4 weeks from any major surgery
• Patients NOT on warfarin must have a prothrombin time (PT)/international normalized ratio (INR) < 1.4 within 14 days prior to registration
• Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet BOTH of the following criteria within 14 days prior to registration:
• 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 LMW heparin
• Female patients of child-bearing potential must have a negative pregnancy test within 14 days prior to registration
• Patients must be willing and able to comply with study and/or follow-up procedures

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
• Patients who have received previous treatment with bevacizumab for CNS disease are not eligible for participation
• Patients with inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg) are not eligible for participation

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Northwestern Memorial Hospital: Lake Forest Hospital — Lake Forest, Illinois, United States
• Cadence Health - CDH — Warrenville, Illinois, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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