Trial Information

A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

OBJECTIVES:

- Determine the duration of response in patients with newly diagnosed pure and mixed
anaplastic oligodendrogliomas treated with intensive chemotherapy supported by
autologous transplantation.

- Determine the neurological and systemic toxic effects of this regimen in these
patients.

- Determine the relationship of 1p loss of heterozygosity on radiographic response,
progression-free survival, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Mobilization and stem cell harvest: Patients receive filgrastim (G-CSF) subcutaneously
daily for up to 7 days followed by peripheral blood stem cell (PBSC) or bone marrow
(BM) harvest.

- Induction therapy: All patients then receive induction therapy (PCV) comprising of oral
lomustine on day 1, vincristine IV on days 8 and 29, and oral procarbazine on days
8-21. Treatment repeats every 42 days in the absence of progressive disease or
unacceptable toxicity. Patients with prior complete resections receive 3 courses of PCV
then proceed to high-dose chemotherapy and transplantation as described below, provided
tumor has not recurred. Patients with prior partial resections or biopsies receive 2
courses of PCV and are assessed for response; those who achieve complete response (CR)
or major partial response (PR) receive 1 more course of PCV. Patients who achieve
partial response or have stable disease receive 2 more courses of PCV and are
reassessed.

- High-dose chemotherapy and transplantation: Patients who achieve CR or PR receive
thiotepa IV on days -8 to -6 and busulfan IV over 2 hours on day -5 to -3. Patients
undergo autologous BM or PBSC transplantation on day 0.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 3-5 years.