Fludarabine and Cyclophosphamide Followed By LMB-2 Immunotoxin in Treating Patients With Hodgkin's Lymphoma

• Status: Withdrawn
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. LMB-2 immunotoxin can find cancer cells and kill them without harming normal cells. Giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin works in treating patients with Hodgkin's lymphoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Immunotoxins; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Histopathologically confirmed CD25+ Hodgkin's lymphoma

• At least 20% of the malignant cells positive by immunohistochemistry

• Stage II-IV disease

• Meets the following criteria:

• Failed standard chemotherapy

• Not eligible for curative salvage radiotherapy or chemotherapy

• Not eligible for or refused bone marrow transplantation

• Measurable disease

• No patient whose serum neutralizes LMB-2 immunotoxin in tissue culture, due either to antitoxin or antimouse-IgG antibodies

• No patient whose serum neutralizes > 75% of the activity of 1 µg/mL of LMB-2 immunotoxin

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 50,000/mm³

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• ALT and AST ≤ 2.5 times upper limit of normal

• Albumin ≥ 3.0 g/dL

• Bilirubin ≤ 2.2 mg/dL (< 5 mg/dL if Gilbert's syndrome is present)

• Creatinine ≤ 1.4 mg/dL OR creatinine clearance ≥ 50 mL/min

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness or social situations that would limit study compliance

• No HIV or hepatitis C positivity

• Hepatitis B surface antigen positivity allowed provided patient is receiving lamivudine

• LVEF ≥ 45%

• DLCO ≥ 50% of normal OR FEV_1 ≥ 60% of normal

• No active second malignancy requiring treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No systemic cytotoxic chemotherapy within the past 4 weeks

• No systemic steroids (except stable doses of prednisone ≤ 20 mg/day) within the past 4 weeks

• No monoclonal antibody therapy within the past 12 weeks

• No prior LMB-2 immunotoxin

• No concurrent warfarin