UMC participates in several
National Cancer Group Programs and Protocols investigating new treatments.
UMC also participates in several multicenter trials of new chemotherapeutic
agents. Current trials include:
S9811 - Phase II
Southwest Oncology Group
Phase II Study of Hydroxyurea for Unresectable Meningioma
Treatment:
Hydroxyurea
Eligibility Criteria:
Histologically documented primary, recurrent or residual benign meningioma
which is unresectable, biopsy slides must be available for pathology review;
patient must have measurable disease by CT or MRI scan; patient must have
either progressive meningioma or progressive neurologic deficit; patients
with malignant meningioma or meningiomatosis are not eligible; patient
should have already received radiotherapy unless radiotherapy has been
refused. If prior RT, treatment must have been completed at least one
year prior to study entry, with documented progressive disease since completion
of RT. Pt. must be >= 18 years, SWOG PS 0-2, no prior cytotoxic chemo.
for meningioma; prior RU-486 is allowed; prior glucocorticoids and hormone
replacement therapy are allowed.
S0001 - Phase III
Southwest Oncology Group
A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG)
Plus BCNU versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme
(GBM) and Gliosarcoma
Treatment:
O6-Benzylguanine, BCNU, Radiation Therapy
Eligibility Criteria:
Pts. must have hist. conf. dx of GBM/ gliosarcoma; bx or srg resection
w/in 28 days prior to registration;MRI w/gadolinium after surgery, but
before registration if tumor removal is greater than simple bx; pts who
have had a simple bx only require the preoperative MRI w/gadolinium; note:
bx will be considered a procedure done for diagnostic rather than therapeutic
purposes with NO attempt at debulking; no prior radiation therapy delivered
cephalad to the interspace between the 7th cervical vertebral body and
the 1st thoracic vertebral body; cannot have 3 or more noncontiguous sites
of tumor based on T2 MRI; no prior chemo.; no prior concomitant drugs
with antineoplastic activity; no other invest. drugs or hormanal therapy;
use of corticosteroids allowed provided that the dose is stable or decreasing
following initial srg. prior to obtaining MRI; institutions must be willing
to submit 1-2 H&E slides for central path review and 3-9 unstained
slides for AGT IHC assay; serum creatinine less than or equal to 1.5 x
IULN or creatinine clearance greater than or equal to 60 ml/min, PT/PTT
less than or equal to 120% of the ULN w/i 28 days prior to registration;
DLCO greater than 70% of predicted within 42 days prior to registration;
pts must be at least 18 yrs of age; PS of less than or equal to 2; pts
must not be known to be HIV positive; pts must not be pregnant or nursing;pts
must not have known allergies to any of the study drugs; pts must not
have other medical illesses which in the Inv's opinion cannot be adequately
controlled (see Sect 5.15). Note: Pts may have a CT scan w/IV contrast
if MRI is not medically feasible
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