Trial Information

Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [F] F.G.-PET Scanning

OBJECTIVES:

Primary

- Determine the 2-year progression-free survival (PFS) rate after treatment with
rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with bulky stage
II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma who remain positron
emission tomography (PET)-positive after 3 courses of rituximab, cyclophosphamide,
vincristine, doxorubicin hydrochloride, and prednisone.

Secondary

- Determine the proportion of mid-treatment PET-positive patients who become PET-negative
after 4 courses of R-ICE.

- Determine the PFS of mid-treatment PET-negative patients treated with these regimens.

- Determine the overall survival of patients treated with these regimens.

- Determine the toxicity of these regimens in these patients.

OUTLINE:

- Rituximab and CHOP chemotherapy (R-CHOP): Patients receive rituximab IV,
cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and
oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 4 courses
in the absence of disease progression or unacceptable toxicity. Patients undergo
fludeoxyglucose F18 positron emission tomography (PET) scanning and conventional
restaging during course 3. Based on the PET results, patients are assigned to 1 of 2
treatment groups.

- Group I (PET negative): Patients receive 2 more courses of R-CHOP as above in the
absence of disease progression or unacceptable toxicity.

- Group II (PET positive): Patients receive R-ICE comprising rituximab IV on day 1,
ifosfamide IV continuously over 24 hours and carboplatin IV over 30 minutes on day
2, and etoposide IV over 2 hours on days 1-3. Patients also receive filgrastim
(G-CSF) subcutaneously once daily starting on day 4 and continuing until blood
counts recover. Treatment repeats every 14 days for 4 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 10 years from
the date of study entry.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.