NCT00073918 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-08-18

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

5 Year Overall Survival

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outcome · POSTED

Response Rate

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outcome · POSTED

Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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)
healthy Volunteers: false
maximum Age: 60 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT

Treatment arms and interventions

arm Groups

description
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab 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 transplantation on day 0.
intervention Names
Drug: cyclophosphamide
Drug: etoposide
Radiation: iodine I 131 tositumomab
Procedure: quality-of-life assessment
Procedure: peripheral blood stem cell transplantation
label
Treatment (radio labeled monoclonal antibody, chemotherapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (radio labeled monoclonal antibody, chemotherapy)
description
Given IV
name
cyclophosphamide
other Names
CPM
CTX
Cytoxan
Endoxan
Endoxana
type
DRUG
arm Group Labels
Treatment (radio labeled monoclonal antibody, chemotherapy)
description
Given IV
name
etoposide
other Names
EPEG
VP-16
VP-16-213
type
DRUG
arm Group Labels
Treatment (radio labeled monoclonal antibody, chemotherapy)
description
Given IV
name
iodine I 131 tositumomab
other Names
131-I-anti-B1 antibody
131-I-anti-B1 monoclonal antibody
I131-MOAB-B1
iodine I 131 MOAB anti-B1
iodine I 131 monoclonal antibody anti-B1
type
RADIATION
arm Group Labels
Treatment (radio labeled monoclonal antibody, chemotherapy)
description
Ancillary study
name
quality-of-life assessment
other Names
quality of life assessment
type
PROCEDURE
arm Group Labels
Treatment (radio labeled monoclonal antibody, chemotherapy)
description
Undergo ASCT given via central catheter
name
peripheral blood stem cell transplantation
other Names
PBPC transplantation
PBSC transplantation
peripheral blood progenitor cell transplantation
transplantation, peripheral blood stem cell
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 111
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.
measure
Progression-free Survival
time Frame
At year 3

secondary Outcomes

description
Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.
measure
5 Year Overall Survival
time Frame
Up to 15 years
description
Response rates will be estimated as the percentage of patients
measure
Response Rate
time Frame
From date of transplant through date of relapse/progression or death, assessed up to 15 years
description
Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%
measure
Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0
time Frame
From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years

Full study description

brief Summary: 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
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice