Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed follicular non-Hodgkin lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Southampton NHS Foundation Trust
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisolone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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