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A Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab (Anti-CD20) Antibody, Etoposide and Cyclophosphamide Followed by Autologous Transplantation, for Relapsed or Refractory Non-Hodgkin's Lymphoma


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Anaplastic Large Cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

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Trial Information

A Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab (Anti-CD20) Antibody, Etoposide and Cyclophosphamide Followed by Autologous Transplantation, for Relapsed or Refractory Non-Hodgkin's Lymphoma


PRIMARY OBJECTIVES:

I. To assess the progression-free survival of patients receiving 131 I labeled tositumomab
antibody, etoposide (VP-16) and cyclophosphamide (CY) followed by autologous
transplantation.

II. To examine the potential efficacy of 131 I labeled tositumomab antibody, etoposide
(VP-16) and cyclophosphamide (CY) followed by autologous transplantation.

SECONDARY OBJECTIVES:

I. To assess the overall survival of patients receiving 131 I labeled tositumomab antibody,
etoposide (VP-16) and cyclophosphamide (CY) followed by autologous transplantation.

II. To evaluate the toxicity and tolerability of the above therapy.

OUTLINE:

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab intravenously
(IV) on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131
tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation
isolation until day -4.

CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell
transplant on day 0.

After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and
then annually thereafter.


Inclusion Criteria:



- 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

- 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 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 renal function (creatinine [Cr] < 2.0)

- 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

- Patients must have an expected survival of > 60 days and must be free of major
infection

Exclusion Criteria:

- Circulating anti-mouse antibody (HAMA)

- Systemic anti-lymphoma therapy given within 30 days prior to anticipated treatment
date

- Inability to understand or give an informed consent

- Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord,
or over 25% of red marrow)

- Central nervous system lymphoma

- 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.)

- Pregnancy

- Prior bone marrow or stem cell transplant

- 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

- Southwest Oncology Group (SWOG) performance status >= 2.0

- Unable to perform self-care during radiation isolation

- 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.

Outcome Time Frame:

At year 3

Safety Issue:

No

Principal Investigator

Ajay Gopal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

1368.00

NCT ID:

NCT00073918

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Anaplastic Large Cell Lymphoma
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109