Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT ID: NCT00073931

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2014-07-31

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with autologous stem cell transplantation in treating older patients who have relapsed or refractory non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

Primary

• Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation.

Secondary

• Determine the overall survival of patients treated with this regimen.
• Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE:

• Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until day -4.
• Autologous stem cell transplantation: Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning on day 0 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

filgrastim

5 µg/kg/day subcutaneously

Intervention Type: BIOLOGICAL

sargramostim

250µg/m2/d subcutaneously

Intervention Type: BIOLOGICAL

autologous bone marrow transplantation

autologous stem cells given via central catheter

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

autologous stem cells given via central catheter

Intervention Type: PROCEDURE

tositumomab and iodine I 131 tositumomab

given intravenously (test dose of 1.7-10 mg/kg tositumomab antibody radiolabeled with \~10 mCi I-131) or via central catheter (therapy dose of 1.7-10 mg/kg tositumomab radiolabeled with individually calculated therapy dose of I-131)

Intervention Type: RADIATION

Other Intervention Names

G-CSF; GM-CSF

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-Hodgkin's lymphoma
• CD20+ disease
• Failed at least 1 prior standard systemic therapy
• Persistent lymphoma by physical examination, radiographic studies, bone marrow evaluations, flow cytometry, or polymerase chain reaction
• Tumor burden less than 500 cc by computed tomography or MRI

• No splenomegaly
• Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved

• No circulating lymphoma cells by morphology or flow cytometry at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be used
• 10% or less marrow involvement by flow cytometry or morphology if purged bone marrow is to be used
• No CNS lymphoma
• No chronic lymphocytic leukemia or small lymphocytic lymphoma/well-differentiated lymphocytic lymphoma

PATIENT CHARACTERISTICS:

Age

• 60 to 80

Performance status

• SWOG 0-1

Life expectancy

• More than 60 days

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin less than 1.5 mg/dL

Renal

• Creatinine less than 2.0 mg/dL

Cardiovascular

• No active coronary artery disease

Pulmonary

• FEV_1 at least 70% of expected
• Vital capacity at least 70% of expected

Other

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• Able to perform self-care during radiation isolation
• No major organ dysfunction
• No major infection
• No circulating anti-mouse antibody
• No other serious medical condition considered to represent contraindications to bone marrow transplantation
• No competing causes of death that would predict life span to be less than 10 additional years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior bone marrow or stem cell transplantation

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or more than 25% of red marrow)

Surgery

• Not specified

Other

• More than 30 days since prior systemic antilymphoma therapy

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Ajay K. Gopal, MD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

References

Gopal AK, Rajendran JG, Gooley TA, Pagel JM, Fisher DR, Petersdorf SH, Maloney DG, Eary JF, Appelbaum FR, Press OW. High-dose [131I]tositumomab (anti-CD20) radioimmunotherapy and autologous hematopoietic stem-cell transplantation for adults > or = 60 years old with relapsed or refractory B-cell lymphoma. J Clin Oncol. 2007 Apr 10;25(11):1396-402. doi: 10.1200/JCO.2006.09.1215. Epub 2007 Feb 20.

Reference Type: RESULT

PMID: 17312330 (View on PubMed)

Other Identifiers

CDR0000341125

Identifier Type: REGISTRY

Identifier Source: secondary_id

1366.00

Identifier Type: -

Identifier Source: org_study_id