Clinical Trials

Studies Open to Subject Enrollment

Primary Central Nervous System Lymphoma

OHSU eIRB #1012; OHSU Cancer Institute Number: SOL-05025-L

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

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 (PCNSL)
• 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 to 75 years

Currently open at:

• Oregon Health & Science University, Portland, Oregon
• Hatton Institute, Cincinnati, Ohio

Anaplastic Oligodendroglioma

OHSU IRB # 8507; OHSU Cancer Institute Number: OCI #SOL-04058-L

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

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 to 75 years old
• Other eligibility criteria may apply

Currently open at:

• Oregon Health & Science University, Portland, Oregon
• Hatton Institute, Cincinnati, Ohio

High-Grade Glioma

OHSU eIRB #922; OHSU Cancer Institute Number: ONC-02019-L

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

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 to 75 years old
• Other eligibility criteria may apply

Currently open at:

• Oregon Health & Science University, Portland, Oregon
• Cleveland Clinic Foundation, Cleveland, Ohio
• Hatton Institute, Cincinnati, Ohio

Multiple Tumor Types

OHSU eIRB #1299; OHSU Cancer Institute Number: ONC-98018-L

Intra-arterial Melphalan (L-phenylalanine mustard) Administered in Conjunction with Osmotic Blood-Brain Barrier Disruption in Patients with Brain Malignancies: A Phase I Study

Protocol Summary:

The purpose of this phase I study is to determine the safety and appropriate dose of a chemotherapy drug called melphalan when given into an artery in patients with malignant brain tumors. The melphalan will be given in conjunction with a procedure called blood-brain barrier disruption (BBBD). Treatment is on two consecutive days approximately every four weeks for up to one year.

Major Eligibility Criteria:

• Primary or metastatic brain tumor
• 18 months and older
• At least 28 days must have elapsed since prior chemotherapy or radiotherapy

Currently open at:

• Oregon Health & Science University, Portland, Oregon

Neuro-Imaging Agents

OHSU eIRB #1127; OHSU Cancer Institute Number ONC-98060-L

Multi-disciplinary study: MR, histologic and EM imaging of intravenous superparamagnetic crystalline particles (Combidex) to Brain and Intra-Cerebral Tumors

Protocol Summary:

This research study is for patients with a variety of brain tumors or central nervous system inflammatory lesions. The purpose of the study is to determine the safety and effectiveness of iron particles called Combidex, used for magnetic resonance imaging (MRI). Study participants will have the iron particles infused into a vein over 30-45 minutes. Participants will return to the hospital 24 hours after the infusion for MRI of the head. Following infusion of the iron particles, some participants may be required to remain hospitalized if they are undergoing surgery for their brain tumor. Participants must be available for 1 monthly follow-up appointment.

Major Eligibility Criteria:

• High-grade glioma or
• Brain metastases or
• Meningioma or
• Low-grade glioma or
• Primitive neuro-ectodermal tumor (PNET) or
• CNS inflammatory lesions including multiple sclerosis and stroke
• Prior chemotherapy and/or radiation allowed
• Single or multiple cerebellar or cerebral lesions are permitted
• Must be HIV negative
• Age 18 years or older

Currently open at:

• Oregon Health & Science University, Portland, Oregon

OHSU eIRB #2753; OHSU Cancer Institute Number SOL-06062-LX

Early Assessment of Tumor Response to Therapy Using Ferumoxytol as an MR Contrast Agent in Patients with Glioblastoma Multiforme

Protocol Summary:

The aim of this pilot study is to collect data in assessing the potentials of dynamic magnetic resonance imaging using ferumoxytol, an iron oxide nanoparticle contrast agent versus gadolinium in the evaluation of early response to therapy in patients with glioblastoma multiforme (GBM). Patients with GBM will be scanned at four time points; before radiation therapy (RT), after weeks 3 and 6 of RT, and 3 months after the beginning of RT. Each time point will consist of three visits on consecutive days. On the first day standard MRI with and without gadolinium (0.1 mmol/kg), perfusion, vascular permeability measurements, diffusion weighted imaging (DWI) and time of flight angiography (TOF) will be done. On the second day the same sequences except for the DWI will be repeated using ferumoxytol (2 mg Fe/kg). On the third day scans will be performed to evaluate ferumoxytol enhancement 24 hours after injection.

Major Eligibility Criteria:

• Glioblastoma multiforme (radiologically and histologically confirmed)
• Measurable disease
• No prior cranial chemotherapy and/or radiotherapy
• Age 18 years or older
• Life expectancy at least 6 months
• ECOG performance status at least 2
• Stable dose of dexamethasone throughout the study

Currently open at:

• Oregon Health & Science University, Portland, Oregon

OHSU eIRB #1562

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

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

Currently open at:

• Oregon Health & Science University, Portland, Oregon