NCT00002649

Brief Summary

Randomized phase III trial to compare the effectiveness of interleukin-2 with that of observation following radiation therapy, combination chemotherapy, and peripheral stem cell transplantation in treating patients who have refractory or relapsed non-Hodgkin's lymphoma. Interleukin-2 may stimulate a person's white blood cells to kill non-Hodgkin's lymphoma cells. Giving interleukin-2 after radiation therapy, chemotherapy, and peripheral stem cell transplantation may kill more cancer cells

Trial Health

80
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P25-P50 for phase_3

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

May 1, 1995

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

11.5 years

First QC Date

November 1, 1999

Last Update Submit

February 27, 2013

Conditions

Recurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular Lymphoma

Outcome Measures

Primary Outcomes (3)

  • Overall survival

    Up to 13 years

  • Disease-free survival

    Up to 13 years

  • Frequency and severity of toxicity associated with post-transplant aldesleukin therapy

    Up to 13 years

Study Arms (2)

Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)

EXPERIMENTAL

Part I: Autologous PBSC are harvested before study entry. Patients undergo total body irradiation twice a day on days -8 to -5, high-dose etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2. PBSC are reinfused on day 0 and then G-CSF may be administered subcutaneously or IV on days 0-21. Part II: Within 28-80 days after PBSC transplantation and after recovery from any toxic effects, patients with no active recurrent or progressive disease are randomized to 1 of 2 treatment arms. Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.

Biological: aldesleukinBiological: filgrastimDrug: cyclophosphamideDrug: etoposideRadiation: radiation therapyProcedure: peripheral blood stem cell transplantationProcedure: bone marrow ablation with stem cell support

Arm II (observation only)

NO INTERVENTION

Patients undergo observation only.

Interventions

aldesleukinBIOLOGICAL

Given IV

Also known as: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2
Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)
filgrastimBIOLOGICAL

Given SC or IV

Also known as: G-CSF, Neupogen
Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)
cyclophosphamideDRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)
etoposideDRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213
Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)
radiation therapyRADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation
Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)
peripheral blood stem cell transplantationPROCEDURE

Undergo autologous peripheral blood stem cell transplant

Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)
bone marrow ablation with stem cell supportPROCEDURE

Undergo bone marrow ablation with stem cell support

Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • REGISTRATION # 1
  • All patients must have biopsy proven diagnosis of low, intermediate or high grade malignant non-Hodgkin's lymphoma; transformed lymphomas are eligible
  • Patients with histologic diagnosis of working formulation A (malignant lymphoma small lymphocytic) or working formulation I (malignant lymphoma, lymphoblastic) are not eligible
  • Patients must have relapsed after achieving a complete or partial response to prior therapy, or have never responded to prior therapy
  • Patients must have debulking (salvage) chemotherapy to determine if the disease is sensitive to chemotherapy; the sole exception to this requirement is for patients with intermediate or high grade lymphoma (working formulation D - H or J) whose disease did not respond to, or progressed during, INITIAL chemotherapy
  • Prior therapy is required; concurrent therapy is NOT permitted
  • Patients with low grade lymphoma (working formulation B or C) must have received at least two prior chemotherapy regimens; if the patient has had one or more CR, then the most recent CR must have been less than one year in duration
  • Patients with intermediate or high grade non-Hodgkin's lymphoma (working formulation D - H or J) must have received at least one prior chemotherapy regimen
  • NOTE: Debulking chemotherapy given only to determine sensitivity is not considered in the calculation of number of prior regimens
  • Patients must have a bone marrow aspirate and biopsy obtained within 42 days of stem cell collection or within 42 days prior to registration
  • Patients with a history of seizures or central nervous system involvement by lymphoma are NOT eligible
  • Only patients with a normal cardiac history and physical exam or in lieu of this, an institutionally normal ejection fraction as measured by either ECHO or MUGA scan are eligible; specifically, there should be: no EKG evidence of active cardiac disease (i.e., arrhythmias, ischemia), no history of congestive heart failure (CHF), no history of myocardial infarction or ischemia, no history of arrhythmia (other than bradycardia treated by pacing), no current cardiac medications for the control of CHF or arrhythmias, no S3 gallop rhythm, or peripheral edema, and no chest X-ray findings compatible with CHF; EKG must be performed within 42 days prior to registration
  • All patients must have a pretreatment serum creatinine of =\< 1.5 times the institutional upper limit of normal measured after completion of prior therapy and within 28 days prior to registration
  • Patients must have adequate pulmonary function as measured by a DLCO \>= 65% of predicted or FEV1 \>= 65% of predicted measured after completion of prior therapy and within 120 days prior to registration
  • Patients must have adequate hepatic function as measured by a bilirubin of =\< 1.5 x the institutional upper limit of normal and SGOT or SGPT =\< 2 x the institutional upper limit of normal, measured after completion of prior therapy and within 28 days prior to registration
  • +31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

Related Publications (1)

  • Thompson JA, Fisher RI, Leblanc M, Forman SJ, Press OW, Unger JM, Nademanee AP, Stiff PJ, Petersdorf SH, Fefer A. Total body irradiation, etoposide, cyclophosphamide, and autologous peripheral blood stem-cell transplantation followed by randomization to therapy with interleukin-2 versus observation for patients with non-Hodgkin lymphoma: results of a phase 3 randomized trial by the Southwest Oncology Group (SWOG 9438). Blood. 2008 Apr 15;111(8):4048-54. doi: 10.1182/blood-2007-09-111708. Epub 2008 Feb 6.

    PMID: 18256325DERIVED

MeSH Terms

Conditions

Burkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, Follicular

Interventions

aldesleukinInterleukin-2FilgrastimGranulocyte Colony-Stimulating FactorCyclophosphamideEtoposideRadiotherapyRadiationPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological FactorsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesTherapeuticsPhysical PhenomenaHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTransplantationSurgical Procedures, Operative

Study Officials

  • John Thompson

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1995

Primary Completion

November 1, 2006

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)