Treatment > Retinoids · Temozolomide Clinical Trials

Meeting Abstract

Phase II study of concurrent temozolomide and cis-retinoic acid with radiation for newly diagnosed glioblastoma multiforme

Susan M Chang, Martin K Nicholas, David Larson, William Wara, Patricia Sneed, Michael Prados

Neuro-Onc Svc UCSF, San Francisco, CA; UCSF, San Francisco, CA

This is a preliminary report of a phase II study of the use of radiation therapy (RT) with the chemotherapeutic agent Temozolomide (TMZ) and the differentiating agent cis-retinoic acid (CRA), for patients (pts) with newly diagnosed glioblastoma multiforme (GM). 
The objectives are to determine if this strategy can improve upon the median survival of GM pts and to evaluate toxicity. Eligibility include age >18 years, KPS of at least 60, normal hematologic and serum chemistry parameters, no prior therapy for GM, initiation of therapy within 5 weeks of surgery and informed consent. 
The RT parameters are a total dose of 60Gy delivered in 2Gy fractions over 6 weeks. 
TMZ is administered starting the first day of RT at 75mg/m2 daily for the duration of radiation therapy. 
At the completion of radiation therapy, the TMZ is administered at 150mg/m2 daily for 5 days every month with the allowance of dose escalation to 200mg/m2. 
CRA is started on day 1 of RT at 100mg/m2/day for 3 weeks with a one week break every month. 
Therapy is continued until disease progression, unacceptable toxicity or a maximum of 1 year. 
Dose adjustments of TMZ and CRA were allowed. 
Pts are evaluated for toxicity and response at the end of radiation therapy, and then every 2 months. 
From 4/01-11/01, 32pts (18 males) of a planned accrual goal of 60 have enrolled. 
Median age is 55yrs (range 32.5-69.7), with median KPS of 90. 
Myelosuppression has been noted in 6 pts (neutropenia- 1 grade 4, 1 grade 3; thrombocytopenia- 2 grade 2). 
Chelitis was also noted (1 grade 3, 1 grade 2 and 4 grade 1). 
2/10 pts evaluated for response after RT have progressed and 3 pts have expired of tumor progression. 
Further accrual and followup continue for assessment of efficacy.

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