NCT00073931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

7.6 years

First QC Date

December 10, 2003

Last Update Submit

February 3, 2015

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival measured continuously

    from date of transplant through date of death

Interventions

filgrastimBIOLOGICAL

5 µg/kg/day subcutaneously

Also known as: G-CSF
sargramostimBIOLOGICAL

250µg/m2/d subcutaneously

Also known as: GM-CSF
autologous bone marrow transplantationPROCEDURE

autologous stem cells given via central catheter

peripheral blood stem cell transplantationPROCEDURE

autologous stem cells given via central catheter

tositumomab and iodine I 131 tositumomabRADIATION

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)

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Related 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 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.

    PMID: 17312330RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-Cell

Interventions

FilgrastimGranulocyte Colony-Stimulating FactorsargramostimGranulocyte-Macrophage Colony-Stimulating FactorPeripheral Blood Stem Cell Transplantationtositumomab I-131

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Ajay K. Gopal, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2003

First Posted

December 11, 2003

Study Start

October 1, 1999

Primary Completion

May 1, 2007

Study Completion

July 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

US(1)