Melphalan, Yttrium Y 90 Ibritumomab Tiuxetan, and Rituximab Followed by Autologous Stem Cell Transplant in Treating Older Patients With Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy drugs, such as melphalan, before an autologous stem cell transplant helps stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Also, monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Chemotherapy and monoclonal antibody therapy also prepares the patient's bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as G-CSF, and vinorelbine helps stem cells move from the bone marrow to the blood so they can be collected and stored. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and monoclonal antibody therapy.

PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab followed by autologous stem cell transplant in treating older patients with non-Hodgkin's lymphoma that has relapsed or not responded to previous treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Antibodies, Monoclonal; Melphalan; Rituximab; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-Hodgkin's lymphoma of any type

• CD20-positive disease

• Achieved partial or complete response to salvage treatment for relapse or refractory disease within the past 10 weeks

• Must have an indication for autologous stem cell transplantation

• Bone marrow infiltration < 25%

• No evidence of CNS involvement

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2 times ULN

• AST ≤ 2 times ULN

• Creatinine clearance > 50 mL/min

• No clinically significant cardiac disease, including any of the following:

• Unstable angina pectoris

• Significant arrhythmia

• Myocardial infarction within the past 3 months

• LVEF > 50%

• No clinically significant urinary tract obstruction

• No clinically significant pulmonary disease

• No serious underlying medical condition that would preclude study participation

• No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated in situ cervical cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 30 days since prior participation in another clinical trial

• No prior stem cell transplantation

• No prior radiolabeled antibodies, including for induction of disease remission

• No prior radiotherapy to ≥ 25% of the bone marrow

• No concurrent radiotherapy

• No other concurrent anticancer drugs

• No other concurrent investigational drugs