|
|
Phase II study of
thalidomide and daily cyclophosphamide for adults with malignant glioma
A. Desjardins, J. A. Quinn, D. A. Reardon, J. N. Rich, J. J. Vredenburgh, C.
Efird, H. S. Friedman
Duke Medical Center, Durham, NC
Background.
We performed a phase II study to determine the activity and
toxicity of thalidomide plus daily cyclophosphamide in patients with recurrent
anaplastic astrocytomas (AA) and anaplastic oligodendrogliomas (AO).
Methods.
Eligibility: adult patients with AA or AO in first relapse with
measurable disease; interval of at least 3 weeks between surgical resection or 6
weeks between radiotherapy or chemotherapy; Karnofsky > 60%; negative
pregnancy test; and adequate marrow, renal, and hepatic function.
Thalidomide was begun at 100 mg at bedtime and increased
by 100 mg weekly to a maximum dose of 400 mg.
Cyclophosphamide was administered at 100 mg daily.
Responses were assessed every eight weeks and patients
remained on study for up to one year or until disease progression or
unacceptable toxicity.
Results.
To date, 11 patients with recurrent AA (n = 10) or AO (n=1) have
been enrolled (planned accrual=30).
Median age is 38 years (range: 27 to 51).
All patients received prior radiation therapy and
chemotherapy (median: 2, range: 1 to 3).
Grade 3 or greater toxicities included neutropenia (grade
3, n=3; grade 4, n=2), and hyponatremia (grade 3, n=1).
Responses include one complete and one partial, both of
these patients completed one year of treatment and remain off therapy with no
evidence of disease progression.
One patient achieved stable disease and is in the 21st
week of therapy.
Five patients progressed after cycle one.
Two patients are too early for evaluation and one patient
died of intratumoral hemorrhage after six days on protocol.
Conclusions.
Thalidomide plus daily cyclophosphamide demonstrates
encouraging activity and is well tolerated among patients with recurrent AA or
AO.
Copyright 2004 American Society of Clinical Oncology All rights
reserved worldwide.
Source: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-003791,00.asp
|
