A Phase I/II Study of Patients with Newly Diagnosed Primary Central Nervous System Lymphoma Treated with Methotrexate/BBBD, and Adding Rituximab (an anti CD-20 Antibody) and Carboplatin to the Treatment Regimen

OHSU eIRB#: IRB00001012; OHSU Knight Cancer Institute Number: SOL-05025-L

Protocol Summary:

The purpose of this study is to evaluate the safety and tolerability of chemotherapy delivered in conjunction with a special technique called blood-brain barrier disruption (BBBD) in patients with primary central nervous system lymphoma (PCNSL) who have not undergone prior cranial or spinal radiotherapy. Participants of this study will be hospitalized for approximately three days every four weeks, to receive chemotherapy. The drug rituximab will be administered intra-venously, the evening prior to carboplatin (intra-arterial) and methotrexate (intra-arterial) chemotherapy. The two chemotherapy drugs will be administered in conjunction with BBBD. If the patient has lymphoma in the eye, chemotherapy will be given into the eye(s) as well. Participants will receive the drug sodium thiosulfate (intra-venous) four and eight hours after carboplatin, in an effort to reduce side effects associated with this chemotherapy regimen. The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.

Major Eligibility Criteria:

• Primary Central Nervous System Lymphoma
• No prior cranial or spinal radiotherapy
• No systemic lymphoma
• No more than 90 days since diagnosis of PCNSL
• Must be HIV negative
• Must be Hepatitis B and Hepatitis C negative
• Age 18-75 years

Currently open at:

• Oregon Health & Science University, Portland, Oregon

For more information:

www.clinicaltrials.gov NCT00293475 

Phase I/II Study of Carboplatin, Melphalan and Etoposide Phosphate in Conjunction with Osmotic Opening of the Blood-Brain Barrier and Delayed Intravenous Sodium Thiosulfate Chemoprotection, in Subjects with Anaplastic Oligodendroglioma or Oligoastrocytoma

OHSU eIRB#: IRB00002868; OHSU Knight Cancer Institute Number: SOL-04058-L

Protocol Summary:

The purpose of this study is to evaluate the safety and tolerability  of chemotherapy delivered in conjunction with a special technique called blood-brain barrier disruption (BBBD) in patients with anaplastic oligodendroglioma  or oligoastrocytoma. The study will also examine the efficacy(one year progression free survival) of the chemotherapy. Participants of this study will be hospitalized for approximately three days every four weeks, to receive chemotherapy. Chemotherapy drugs will include carboplatin(intra-arterial), melphalan (intra-arterial), and etoposide phosphate(intravenous). The three chemotherapy drugs will be administered in conjunction with BBBD. Participants will receive the drug sodium thiosulfate (intra-venous)four and eight hours after carboplatin, in an effort to reduce side effects associated with this chemotherapy regimen. The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.

Major Eligibility Criteria:

• Anaplastic oligodendroglioma or oligoastrocytoma
• Prior treatment with Temozolomide
• Prior consultation with radiation oncology
• Aged 18-75 years old
• Other eligibility criteria may apply

Currently open at:

• Oregon Health & Science University, Portland, Oregon

For more information:

www.clinicaltrials.gov NCT00303849

Phase II Clinical Trial of Patients with High-Grade Glioma Treated with Intra-arterial Carboplatin-based Chemotherapy, Randomized to Treatment with or without Delayed Intravenous Sodium Thiosulfate as a Potential Chemoprotectant Against Severe Thrombocytopenia

OHSU eIRB #: IRB00000922; OHSU Knight Cancer Institute Number: ONC-02019-L

Protocol Summary:

The purpose of this study is to evaluate if the drug called sodium thiosulfate prevents a severe decrease in a particular type of blood cell (platelets) in patients who are being given carboplatin, cyclophosphamide, and etoposide phosphate for the treatment of high-grade glioma. This is a randomized study meaning that neither the participant nor their doctor may choose to which treatment group the participant is assigned. All participants of this study receive the chemotherapy drugs carboplatin (intra-arterial),cyclophosphamide (intravenous) and etoposide phosphate (intravenous). Participants will be randomized in two groups. Group 1 will receive the chemotherapy drugs, but not the sodium thiosulfate. Group 2 will receive the chemotherapy drugs, followed by the sodium thiosulfate (intravenous), four and eight hours after the chemotherapy.

Major Eligibility Criteria:

• High-grade glioma
• Age 18-75 years old
• Other eligibility criteria may apply

Currently Open at:

• Oregon Health & Science University, Portland, Oregon

For more information:

www.clinicaltrials.gov NCT00075387

Phase I/II Study of Intra-arterial Melphalan Given with Intra-arterial Carboplatin, Osmotic Blood-Brain Barrier Disruption and Delayed Otoprotective Sodium Thiosulfate for Patients with Recurrent or Progressive CNS Embryonal or Germ Cell Tumors

OHSU eIRB#: IRB00005056; OHSU Knight Cancer Institute Number: SOL-08131-L

Protocol Summary:

The purpose of this study is to determine the safety and effectiveness of the chemotherapy drugs called carboplatin and melphalan, when they are given into an artery, in patients with malignant brain tumors (called embryonal and germ cell tumors). The carboplatin and melphalan will be given during a procedure called blood-brain barrier disruption (BBBD). Patients also receive a drug called sodium thiosulfate in a vein, in order to protect against carboplatin-induced hearing loss.  Participants will be admitted to the hospital every four weeks for approximately three days. The patient will undergo monthly MRI scans of the head, monthly hearing evaluation, as well as weekly blood tests. The patient will also have memory testing done. Treatment will last for up to 12 months.

Major Eligibility Criteria:

• CNS embryonal tumor or germ cell tumor
• 1-30 years old
• Must have had prior therapy (systemic and/or cranial radiation or chemotherapy, neurosurgery and/or radiation oncology)
• At least 28 days must have elapsed since prior chemotherapy or radiotherapy
• Other eligibility criteria may apply

Currently Open at:

• Oregon Health & Science University, Portland, Oregon
• University of Minnesota, Minneapolis, Minnesota

For more information:

www.clinicaltrials.gov NCT00983398

NCI-Sponsored Multi-disciplinary Study for MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Suspected or Confirmed Glioblastomas

OHSU eIRB #9846

Protocol Summary:

The purpose of this study is to understand the safety and usefulness of the study agent compared to the standard gadolinium-based contrast agent (GBCA) during magnetic resonance imaging (MRI). MRI is a test that uses a magnetic field and radio waves to produce detailed pictures of the body's organs and structures and GBCAs are used to enhance these pictures.

We would like to find out if the study agent is helpful in viewing your brain tumor and the blood vessels in and around the tumor in a different way on MRI than the standard substance, GBCA.

Since blood vessels supply necessary elements for tumor cells to grow and develop, it is hoped that this new technique may give us more information about tumor blood supply and the extent of the tumor itself. Another goal of this study is to see how the amount of extra blood vessels may help predict a response to therapy or survival.

Major Eligibility Criteria:

• Suspected or confirmed glioblastoma
• Prior to radiation treatment
• Age 18 years or older
• Other eligibility criteria may apply

Currently Open at:

• Oregon Health & Science University, Portland, Oregon

For more information:

www.ClinicalTrials.gov NCT02359097

 

A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3T and 7T in Subjects with Malignant Brain Tumors Either Before or After Therapy

OHSU eIRB #2864; OHSU Knight Cancer Institute Number SOL-06077-L

Protocol Summary:

The purpose of this study is to compare special magnetic resonance (MR) brain imaging techniques (called: dynamic perfusion, blood-brain barrier (BBB) permeability measurement) in two different magnetic fields (3 and7 Tesla) in the evaluation of brain tumors. Two contrast agents will be used;the standard gadolinium, and ferumoxytol, a new, iron containing agent. The investigators think that these new methods will give us better assessment of brain tumors.

Major Eligibility Criteria:

• Histologically or cytologically confirmed primary malignant brain tumors or brain metastasis
• Radiographically measurable disease with standard MR imaging, and the tumor must have an enhancing component
• Patients may or may not have had prior surgery, radiation therapy, or chemotherapy
• At least 4 weeks since prior surgical resection
• Age 18 years or older
• ECOG performance status <3
• Other eligibility criteria may apply

Currently open at:

Oregon Health & Science University, Portland, Oregon

For more information:

www.ClinicalTrials.gov NCT00659126

 

Multi-Disciplinary Study: MR, Histologic and EM Imaging of Intravenous Superparamagnetic Crystalline Particles (Ferumoxytol) in CNS Inflammation

OHSU eIRB #1562

Protocol Summary:

The primary aim of this study is to compare ferumoxytol MR with the "gold standard" gadolinium enhanced MR in adults with inflammatory or demyelinating brain disease (multiple sclerosis) or in adults with ischemic brain process (stroke, carotid stenting/surgery). We will also identify inflammatory and embolic lesions in the brain of patients undergoing cardiac surgery with or without cardiopulmonary bypass utilizing ferumoxytol enhanced MRI. The secondary objective of this study is to localize ferumoxytol particles with histology and electron microscopy in biopsy samples from a small subset of patients with CNS inflammatory lesions in which the diagnosis is unclear and biopsy is needed to exclude lymphoma or other alternative diagnosis and compare with imaging results. Each subject will have an initial diagnostic MRI and MRA of the brain with gadolinium; this will be the baseline study for further comparison. On the second day the subject will undergo an anatomical MRI with ferumoxytol, which may include DWI, MRA or perfusion study. On the third day scans will be performed to evaluate ferumoxytol enhancement 24 hours after injection. (MR may be performed at later times at physician's direction.)

Major Eligibility Criteria:

• CNS inflammatory lesion, multiple sclerosis, stroke (clinically, radiologically or histologically confirmed), carotid or cardiac surgery
• Pre-treatment radiological scans for subjects receiving ferumoxytol must be performed within 28 days prior to study entry
• Age 18 years or older
• Other eligibility criteria may apply

Currently open at:

Oregon Health & Science University, Portland, Oregon

For more information:

www.ClincalTrials.gov NCT00659776