- To evaluate the response rates in patients with relapsed follicular non-Hodgkin lymphoma treated with short-duration rituximab and combination chemotherapy (R-chemo) followed by rituximab and yttrium Y 90 ibritumomab tiuxetan.
- To evaluate the duration of response in patients treated with this regimen.
- To evaluate the quality of response in order to determine the conversion rate from partial response to complete response in patients treated with this regimen.
- To evaluate the toxicity of yttrium Y 90 ibritumomab tiuxetan when administered after 3 courses of R-chemo.
OUTLINE: This is a multicenter study.
- Chemoimmunotherapy (R-CHOP or R-CVP): Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Alternatively, patients who have already been exposed to prior tolerance doses of anthracyclines receive R-CVP comprising rituximab IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 3 weeks for up to 3 courses.
Patients with objective evidence of response on CT scan or those with < 25% bone marrow involvement and no signs of bone marrow hypocellularity (< 15%) on bone marrow biopsy proceed to radioimmunotherapy.
- Radioimmunotherapy: Four to 6 weeks after completion of R-CHOP or R-CVP, patients receive rituximab IV followed no more than 4 hours later by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes.
After completion of study therapy, patients are followed periodically for up to 5 years.
- Histologically confirmed grade 1, 2, or 3 follicular non-Hodgkin lymphoma
- Stage II, III, or IV disease (according to the Ann Arbor staging system)
- CD20-positive disease
- Initial disease bulk ≤ 10 cm
- In first or second relapse after prior treatment with a rituximab-containing chemotherapy regimen (R-chemo) or chemotherapy alone
- Relapse must have occurred ≥ 6 months after completion of R-chemo
- Relapse that occurred < 6 months after completion of chemotherapy alone allowed
- Has at least one of the following symptoms requiring initiation of treatment:
- Nodal mass > 5 cm in its greater diameter
- B symptoms
- Elevated serum lactate dehydrogenase (LDH) or β2-microglobulin
- Involvement of ≥ 3 nodal sites (each with a diameter > 3 cm)
- Symptomatic splenic enlargement
- Compressive syndrome
- No primary refractory disease
- No large pleural or peritoneal effusions
- No CNS disease
- ECOG performance status 0-2
- Life expectancy ≥ 6 months
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 1,000/mm³
- Serum creatinine < 1.5 times upper limit of normal (ULN)
- Total bilirubin < 1.5 times ULN
- AST < 5 times ULN
- No active obstructive hydronephrosis
- No evidence of active infection requiring IV antibiotics
- No advanced heart disease or other serious illness that would preclude study evaluation
- No known HIV infection
- No human anti-mouse antibody (HAMA) reactivity
- No known hypersensitivity to murine antibodies or proteins
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- No other prior malignancy, except for adequately treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior investigational drugs and recovered
- No prior radioimmunotherapy
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|