Clinical Trial · NCT00073918

Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Overview

This phase II trial is studying how well giving iodine I 131 tositumomab together with etoposide and cyclophosphamide followed by autologous stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining a radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell transplant may kill more cancer cells

Sponsor

Fred Hutchinson Cancer Center

Phase

Phase 2

Contacts

Ajay Gopal (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00073918

Drug / Compound

tositumomab

Isotope(s):

Target(s):

cd20

Ligand Class: Antibodies

Eligibility

Inclusion

Patients must have an expected survival of \> 60 days and must be free of major infection
Note: Patients with clinically non-transformed follicular lymphomas do not require repeat biopsies for immunophenotyping since these tumors are uniformly reactive with the tositumomab antibody
Patients must have a histologically confirmed diagnosis of lymphoma expressing the cluster of differentiation (CD)20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) in accordance with current transplant standard of care for these patients
Patients must have normal renal function (creatinine \[Cr\] \< 2.0)
Patients must have tumor burdens \< 500cc by computed tomography (CT) or magnetic resonance (MRI) volumetric measurements and must not have splenomegaly at the time of enrollment; splenomegaly will be defined as a spleen volume \> 2 standard deviations of the mean spleen volume to body weight ratio (mean = 3.84 cc/kg, SD = 1.53 cc/kg); thus, patients with \> 6.9cc/kg will be defined as having splenomegaly; patients with splenomegaly that is thought to be due to G CSF/GM-CSF effect and not due to lymphomatous involvement of the spleen can been deemed eligible with the approval of an investigator
Patients must have normal hepatic function (bilirubin \< 1.5mg/dL), with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5mg/dL
All patients eligible for therapeutic study must have autologous hematopoietic stem cells (2 x 10\^6 CD34+ cells/kg) harvested and cryopreserved

Exclusion

Prior radiation \> 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or over 25% of red marrow)
Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma/well differentiated lymphocytic lymphoma (ineligible because these tumors express very low surface densities of CD20)
Systemic anti-lymphoma therapy given within 30 days prior to anticipated treatment date
Presence of circulating lymphoma cells by morphology or flow cytometry (\>= 0.1%) at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSC are to be used
Central nervous system lymphoma
Southwest Oncology Group (SWOG) performance status \>= 2.0
Circulating anti-mouse antibody (HAMA)
Prior bone marrow or stem cell transplant
Unable to perform self-care during radiation isolation
Pregnancy
Other serious medical conditions considered to represent contraindications to autologous stem cell transplant (ASCT) (e.g., active coronary artery disease, pulmonary dysfunction \[forced expiratory volume in 1 second (FEV1) \< 70% expected, Vital Capacity \< 70% expected, diffusing capacity of the lung for carbon monoxide (DLCO) \< 50%, patient on supplemental oxygen\], AIDS, etc.)