Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells.

PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.

Conditions

• Lymphoma

Interventions

DRUG

carmustine

Day -6, 300 mg/m\^2 over 2 hour

DRUG

cyclophosphamide

NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days. HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m\^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing.

DRUG

etoposide

NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2. HL without radiation: 150 mg/m\^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4.

PROCEDURE

peripheral blood stem cell transplantation

Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.

RADIATION

irradiation therapy

Patients undergo total body irradiation (TBI) twice daily on days -4 to -1. * \> 1000 cGy to whole lung, kidney, or abdominal bath. * \> 3000 cGy to spinal cord, myocardium, mediastinum, lumbar periaortic lymph nodes. * \> 3600 cGy to whole brain.

BIOLOGICAL

G-CSF

Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) \> 1500/μl x 3 consecutive days. If ANC falls \<1000/μL, restart G-CSF.

DRUG

Cytarabine

100 mg/m\^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Veronika Bachanova, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-08-24

Primary Completion

2019-06-28

Completion

2019-06-28

Countries

• United States

Study Locations