Non Hodgkin Lymphoma Clinical Trial
Radiolabeled Monoclonal Antibody Therapy and High-Dose Chemotherapy Followed By Autologous Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma
Summary
RATIONALE: Radiolabeled monoclonal antibodies such as yttrium Y90 ibritumomab tiuxetan can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining yttrium Y90 ibritumomab tiuxetan and chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with high-dose chemotherapy followed by autologous stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan, in terms of absorbed radiation to critical organs, when administered with high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Determine whether the residual radioactivity detected at the time of stem cell reinfusion affects the reinfused cells and delays engraftment in patients treated with this regimen.
Determine the duration of response and survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).
Radioimmunotherapy: Patients receive rituximab IV followed by indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -22. Patients then receive rituximab IV and IDEC-Y2B8 IV over 10 minutes on day -14.
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.
High-dose conditioning regimen: Patients receive BEAM chemotherapy comprising carmustine IV over 2 hours on day -6, etoposide IV over 2 hours twice daily and cytarabine IV over 1 hour twice daily on days -5 to -2, and melphalan IV over 1 hour on day -1.
Autologous stem cell transplantation: Autologous peripheral blood stem cells are reinfused on day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover.
Patients are followed at 30 days, 3 and 6 months, and then annually for 5 years.
PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed B-cell non-Hodgkin's lymphoma
Relapsed or refractory disease
CD20-positive disease
Must have received at least 1 prior treatment regimen
Complete remission with prior conventional salvage chemotherapy is allowed
No more than 25% lymphoma in bone marrow
No circulating malignant cells on blood smear
No CNS involvement by lymphoma
No HIV- or AIDS-related lymphoma
PATIENT CHARACTERISTICS:
Age
Over 17
Performance status
ECOG 0-2
Life expectancy
At least 3 months
Hematopoietic
Platelet count at least 100,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Hepatic
Transaminases less than 2 times normal
Renal
Creatinine clearance greater than 50 mL/min
Cardiovascular
LVEF at least 45%
Pulmonary
Corrected DLCO at least 70% of predicted
FEV_1 or FVC greater than 60%
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection
No serious nonmalignant disease or other condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
More than 4 weeks since prior rituximab and recovered
No other prior murine antibodies
No prior stem cell transplantation
No prior radioimmunoconjugate therapy
Chemotherapy
See Disease Characteristics
More than 6 weeks since prior nitrosoureas or mitomycin and recovered
Endocrine therapy
No concurrent systemic corticosteroids
Radiotherapy
Recovered from prior radiotherapy
No prior external beam irradiation to more than 25% of the active bone marrow
Surgery
More than 4 weeks since prior major surgery and recovered
Other
More than 3 weeks since prior anticancer therapy
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There are 2 Locations for this study
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Rochester Minnesota, 55905, United States
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