Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT01338857
Eligibility Criteria:
Inclusion Criteria:
* Age: greater than or equal to 2 years of age
* Patients with neurofibromatosis-1 (NF1) are eligible
* Recurrent/progressive optic pathway gliomas (OPG) by MRI criteria, after standard therapy - histologic confirmation not required OR Histologically confirmed, radiographically recurrent or progressive low-grade glioma (WHO grade I or II) by MRI criteria, after standard therapy.
* Karnofsky performance status (PS) 60-100% (greater than or equal to 16 years of age) OR Lansky PS 60-100% (\< 16 years of age)
* Absolute neutrophil count ≥ 1,000/mm³ (unsupported)
* Platelet count ≥ 75,000/mm³ (unsupported)
* Normal PT, PTT, and INR (for patients on prophylactic anticoagulation only)
* Diastolic blood pressure (DBP) ≤ the 95th percentile for age and gender and not currently receiving medication for the treatment of hypertension.
* Adequate pulmonary function, defined as: no evidence of dyspnea at rest, no exercise intolerance, and pulse oximetry \> 94% if termination is clinically indicated.
* Not received myelosuppressive chemotherapy or treatment with biologicals or monoclonal antibodies within 4 weeks of enrollment onto this study (6 weeks if prior nitrosurea)
* At least 7 days since the completion of therapy with a hematopoietic growth factor and at least 14 days from the last administration of PEGylated GCSF (Neulasta®)
* If prior radiation therapy, ≥ 6 months must have elapsed since the last fraction for craniospinal therapy and ≥ 3 months for focal radiotherapy including radiosurgery.
* If prior surgery, ≥ 8 weeks must have elapsed since (≥ 4 weeks for minor surgery/procedures including central line placement)
* Steroids are allowed for progressive symptoms but patient must be on a stable or decreasing dose for at least 1 week prior to study entry
* Any neurologic deficits must be stable for ≥ 1 week
Exclusion Criteria:
* Patients with serious concurrent infection or medical illness, including overt hepatic or renal disease, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
* Baseline hypertension greater than grade 1.
* Prior treatment with sorafenib
* Other concurrent investigational drugs
* Other concurrent anticancer agents or therapies, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
* Concurrent therapeutic anticoagulation. Prophylactic anticoagulation (i.e. low dose heparin) of venous or arterial access devices is allowed.
* Concurrent administration of any of cytochrome P450 enzyme-inducing agents, including grapefruit juice and drugs listed under Section 9.7.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
* Uncontrolled hypertension Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
* Active clinically serious infection
* Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
* Pulmonary hemorrhage/bleeding event
* Any other hemorrhage/bleeding event
* Serious non-healing wound, ulcer, or bone fracture.
* Evidence or history of unresolved bleeding diathesis or coagulopathy.
* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
* Known or suspected allergy to sorafenib.
* Any malabsorption problem.
* Patients with history of any prior CNS bleeding.
* Patients with any non-healed wounds.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT01338857
Study Brief:
Protocol Section:
NCT01338857