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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Carmustine; Cytarabine; Etoposide; Etoposide phosphate; Lenograstim; Melphalan; Rituximab; Sargramostim

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