Clinical 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 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:
OHSU
eIRB #641; OHSU Cancer Institute Number: ONC-02059-LX
A Phase II Trial
Involving Patients with Recurrent PCNSL Treated with Carboplatin/BBBD,
by Adding Rituxan
(Rituximab), an anti CD-20 Antibody, to the Treatment Regimen
Protocol Summary: The purpose of this study
is to evaluate the safety and effectiveness of chemotherapy
delivered in
conjunction with a special technique called blood-brain barrier
disruption (BBBD), and chemotherapy administered into the cerebrospinal
fluid,
in patients with relapsed or recurrent primary central nervous
system lymphoma. Participants of this study will be hospitalized
for approximately
three days every four weeks to receive chemotherapy. The drug rituxan
will be administered intra-venously, the evening prior to carboplatin
(intra-arterial), cyclophosphamide (intravenous), and etoposide
phosphate (intravenous) chemotherapy. The latter three chemotherapy
drugs will
be administered in conjunction with BBBD. Participants will receive
the drug sodum thiosulfate (intravenous) four and eight hours
after carboplatin, in an effort to reduce side effects associated
with this
chemotherapy regimen. Two weeks after the chemotherapy is given
a drug called ARA-C (cytarabine) may be given into the cerebrospinal
fluid. The treatment may continue for up to 12 months in the absence
of disease progression or unacceptable side effects.
Major Eligibility Criteria:
- Relapsed or recurrent primary central nervous system lymphoma
(PCNSL)
- CD20 positive
- Disease progression occurred while undergoing or at completion
of methotrexate-based chemotherapy
- Age 18 months to 75 years
- Other eligibility criteria may apply
Currently open at:
- Oregon Health & Science University,
Portland, Oregon
- University of Oklahoma,
Oklahoma City, Oklahoma
- Ohio State University Medical
Center,
Columbus, Ohio
- Hadassah-Hebrew
University Medical Center, Jerusalem, Israel
- University
of Kentucky, Lexington, Kentucky
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:
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:
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:
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 or older
Currently open at:
|