OHSU

Clinical Trials

Studies Open to Subject Enrollment

Oregon Health & Science University (OHSU), Portland Veterans Affairs Medical Center (PVAMC) and the Department of Veterans Affairs have a significant financial interest in Adherex, a company that may have a commercial interest in the results of this research and technology. This potential conflict of interest has been reviewed and managed by the OHSU Integrity Program Oversight Council and the PVAMC Conflict of Interest in Research Committee.
 

Primary Central Nervous System Lymphoma

 

OHSU eIRB #1012; OHSU Knight 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
  • Ohio State University Medical Center, Columbus, Ohio

For more information:

 

Anaplastic Oligodendroglioma

 

OHSU IRB # 2868; OHSU Knight Cancer Institute Number: 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
  • University of Minnesota, Minneapolis, MN

For more information:

 

High-Grade Glioma

 

OHSU eIRB #922; OHSU Knight 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
  • University of Minnesota, Minneapolis, MN

For more information:

www.ClinicalTrials.gov  NCT00075387

 

Multiple Tumor Types

 

OHSU eIRB #1299; OHSU Knight 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

For more information:

 

Central nervous system embryonal & germ cell tumors

 

OHSU eIRB #5056; OHSU Knight Cancer Institute Number: SOL-08131-L

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

 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 Year to 30 Years
  • 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, MN
For more information: 


Neuro-Imaging Agents

 

OHSU eIRB #813; OHSU Knight Cancer Institute Number:   ONC-03095-LX

NCI-Sponsored multi-disciplinary study for MR imaging of intravenous superparamagnetic crystalline particle ferumoxytol in primary high-grade brain tumors and/or cerebral metastases from lung or breast cancer

Protocol Summary:

This protocol revision seeks to expand upon the data originally collected from 12 patients who received ferumoxytol. The results of the original protocol were published in 2007 in Neurosurgery. We found that maximal ferumoxytol enhancement intensity occurred at 24 to 28 hours after administration, and the enhancing volume subsequently expanded with time into a non-gadolinium-enhancing, high T2-weighted signal region of tumor-infiltrated brain. Dynamic studies were assessed with both agents and demonstrated that gadolinium leaks out of blood vessels early after injection, whereas ferumoxytol stays intravascular in the "early" phase, thereby increasing the accuracy of tumor perfusion assessment.

This protocol revision to the preliminary trial will characterize vascular properties of tumors in the CNS using ferumoxytol for DSC MRI to compare with those obtained using GBCA for DCE in a single MR imaging session. Furthermore, these imaging properties of various malignant CNS tumors will be characterized longitudinally with up to 6 imaging session over approximately 2 years. The information obtained in this study may guide the creation of a new imaging criteria to evaluate tumor progression and pseudoprogression secondary to RCT in the context of wide-spread use of antiangiogenic agents. We expect that the objectives of this study will be achievable in a single imaging session.

Major Eligibility Criteria:

  • High-grade glioma/CNS lymphoma or brain metastases from lung or breast cancer.
  • Measurable disease
  • May have had prior therapy for the primary brain tumor or metastatic disease, including radiotherapy or chemotherapy
  • Age 18 years or older
  • Other eligibility criteria may apply

Currently open at:

  • Oregon Health & Science University, Portland, Oregon 

For more information:

 

OHSU eIRB #5405; OHSU Knight Cancer Institute Number SOL-09064-LX

Imaging vascular properties of pediatric brain tumors using DSC-MRI with ferumoxytol (Code 7228) and DCE-MRI with gadolinium in a single imaging session:   An NCI sponsored exploratory trial

Protocol Summary:

Current imaging techniques often do not demonstrate the true amount and location of brain tumors, which are both critical factors for treatment decision-making. This purpose of this study is to assess the safety and effectiveness of a new iron containing agent called "ferumoxytol" in improving our ability to image pediatric brain tumors. Ferumoxytol, as well as the usual contrast agent, gadolinium, together will be used to image the blood vessels in pediatric brain tumors. After contrast agent injection into the veins, special magnetic resonance imaging (MRI) scans will be performed to see changes in blood vessels in the brain and tumor.

Major Eligibility Criteria:

  • Radiological (presumptive) or established (proven) histological diagnosis of a brain tumor or lesion
  • Previously untreated patients must have a measureable lesion on an imaging study
  • Patients undergoing active treatment, or who have completed treatment, will have radiographic abnormalities that may or may not be recurrent tumor
  • Patients may have had prior therapy for the primary brain tumor, including surgery, radiotherapy or chemotherapy
  • Up to age 18 years
  • Other eligibility criteria may apply

Currently open at:

  • Oregon Health & Science University, Portland, Oregon
For more information:



OHSU eIRB #2753; OHSU Knight 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

For more information:


OHSU eIRB #3678; OHSU Knight Cancer Institute Number SOL-07083-LX

Pilot Study to Compare Dynamic MR Imaging Changes in Patients with Recurrent High Grade Glioma, Receiving an Antiangiogenic Drug, Bevacizumab, Versus Dexamethasone. Dual Agent MR Imaging Study, Using Gadolinium and Ferumoxytol

Protocol Summary:

The purpose of this study is to learn more about imaging changes induced by a new therapeutic agent, bevacizumab with the standard steroid, dexamethasone in patients with high grade glioma. Magnetic resonance imaging (MRI) will be used to evaluate the difference between the 2 treatments. The usual contrast agent (gadolinium) and an iron containing contrast agent called "ferumoxytol" may help us to evaluate the differences between bevacizumab and dexamethasone effects on imaging of a brain tumor called high grade glioma. For this purpose, after intravenous contrast agent injection, special MR scans (called: dynamic perfusion, blood-brain barrier (BBB) permeability measurement) will be performed to see the microvascular changes in the brain and tumor.

Major Eligibility Criteria:

  • Histologically confirmed high grade glioma
  • Radiographic demonstration of disease progression following prior therapy of temazolomide + radiation
  • Patient scheduled for bevacizumab + standard IV chemotherapy therapy
  • At least 4 weeks since prior surgical resection
  • Age 18 years or older
  • Karnofsky performance status greater than or equal to 70
  • Other eligibility criteria may apply

Currently open at:

  • Oregon Health & Science University, Portland, Oregon
For more information:

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

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

 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 and 7 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:

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

For more information:

www.ClinicalTrials.gov  NCT00659776

 

 

N-acetylcysteine for the prevention of contrast induced nephropathy


OHSU eIRB #3973

Dose escalation study of intravenous and intra-aortic  N-acetylcysteine for the prevention of contrast induced nephropathy in patients with stage 3 renal failure undergoing contrast imaging studies: a Phase I trial

 Protocol Summary:

This is a randomized prospective dose escalation clinical study of N-acetylcysteine (NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60 ml/min calculated with the Modification of Diet in Renal Disease formula), undergoing a procedure or imaging that requires the administration of contrast media at Oregon Health & Science University or the Portland Veterans Hospital. Subjects will receive NAC 60 minutes prior to the procedure or imaging requiring contrast media. Toxicity will be graded according to NCI Common Toxicity Criteria (CTC) version 3.0.  An adult  Phase 1 dose escalation study of NAC administered intravenously (IV) and intra-arterially (IA) will be performed.  An isotonic nonionic contrast agent will be used in all cases. Contrast Induced Nephropathy (CIN) is defined as an increase in serum creatinine concentration of 25% or more from the subjects baseline value within a 72-hour period after the administration of contrast media. Serum creatinine concentration will be measured at admission, every day during in-patient hospitalization, and at hospital discharge.

Major Eligibility Criteria:

  • Renal failure, stage 3 or worse
  • Undergoing endovascular procedure with an isotonic, non ionized contrast agent
  • Platelets greater than or equal to 100,000/mm3
  • Systolic pressure of greater than 90 mm Hg
  • No contraindications to N-acetylcysteine or contrast agent
  • Not at risk for general anesthesia
  • Not in acute renal failure
  • Not undergoing dialysis
  • Other eligibility criteria may apply

Currently open at:

  • Oregon Health & Science University, Portland, Oregon
For more information: