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

Lymphoma Clinical Trial

Official title:

A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073931
• Other study ID #: 1366.00
• Secondary ID: CDR0000341125
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2003
• Last updated: February 3, 2015
• Start date: October 1999
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2014
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• filgrastim
5 µg/kg/day subcutaneously
• sargramostim
250µg/m2/d subcutaneously

Procedure:
• autologous bone marrow transplantation
autologous stem cells given via central catheter
• peripheral blood stem cell transplantation
autologous stem cells given via central catheter

Radiation:
• 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)

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 year — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival measured continuously		from date of transplant through date of death	No