NCT00036855

Brief Summary

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy with or without peripheral stem cell transplantation in treating patients who have recurrent or refractory lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver radioactive tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by anticancer therapy

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 13, 2002

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

May 13, 2002

Last Update Submit

January 16, 2013

Conditions

AIDS-related Peripheral/Systemic LymphomaAIDS-related Primary CNS LymphomaPost-transplant Lymphoproliferative DisorderRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent/Refractory Childhood Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • MTD, defined as that dose at which fewer than one-third of patients experience DLT graded according to the NCI CTC v 2.0

    Up to day 49

Study Arms (2)

Group A (no planned PBSC support)

EXPERIMENTAL

Patients receive rituximab IV over 4-6 hours followed by IDEC-In2B8 IV over 10 minutes on day 0 and undergo whole body imaging. Patients may then receive rituximab IV over 4-6 hours followed by IDEC-Y2B8 IV over 10 minutes on day 7. Some patients receive autologous PBSC IV over 30-60 minutes on day 35.

Biological: rituximabRadiation: indium In 111 ibritumomab tiuxetanRadiation: yttrium Y 90 ibritumomab tiuxetanProcedure: peripheral blood stem cell transplantationOther: laboratory biomarker analysis

Group B (planned PBSC support)

EXPERIMENTAL

Patients receive rituximab, IDEC-In2B8, and IDEC-Y2B8 as in group A. Patients also receive autologous PBSC IV over 30-60 minutes on day 21 and G-CSF subcutaneously beginning on day 22 and continuing until blood counts recover or day 35.

Biological: rituximabRadiation: indium In 111 ibritumomab tiuxetanRadiation: yttrium Y 90 ibritumomab tiuxetanProcedure: peripheral blood stem cell transplantationBiological: filgrastimOther: laboratory biomarker analysis

Interventions

rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Group A (no planned PBSC support)Group B (planned PBSC support)
indium In 111 ibritumomab tiuxetanRADIATION

Given IV

Also known as: IDEC-In2B8
Group A (no planned PBSC support)Group B (planned PBSC support)
yttrium Y 90 ibritumomab tiuxetanRADIATION

Given IV

Also known as: 90Y ibritumomab tiuxetan, IDEC Y2B8, Y90 Zevalin, Y90-labeled ibritumomab tiuxetan
Group A (no planned PBSC support)Group B (planned PBSC support)
peripheral blood stem cell transplantationPROCEDURE

Undergo PBSC transplantation

Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Group A (no planned PBSC support)Group B (planned PBSC support)
filgrastimBIOLOGICAL

Given subcutaneously

Also known as: G-CSF, Neupogen
Group B (planned PBSC support)
laboratory biomarker analysisOTHER

Correlative studies

Group A (no planned PBSC support)Group B (planned PBSC support)

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed and immunophenotypically (CD20)-positive lymphoma at original diagnosis, progression, or relapse
  • Refractory to conventional therapy
  • First recurrent/refractory CD20-positive non-Hodgkin's lymphoma (NHL) allowed if ineligible for or refused regimens with known curative potential (high-dose chemotherapy plus bone marrow transplantation) (if available)
  • Second or third progression and/or recurrence of NHL
  • Second or third relapse/refractory CD20-positive Hodgkin's lymphoma
  • CD20-positive, post-transplantation lymphoproliferative lymphoma that is medically refractory (decreased immunosuppression) to rituximab and/or chemotherapy
  • Medically refractory, HIV-associated, CD20-positive NHL
  • Recurrent/refractory CD20-positive lymphoblastic lymphoma
  • Autologous peripheral blood stem cells (PBSC) collected, selected for a minimum of 2 x 10\^6 CD34-positive cells per kg, and cryopreserved before study entry
  • Meets one of the following criteria for bone marrow reserve:
  • Good marrow reserve, defined by both of the following:
  • No prior myeloablative stem cell transplantation (SCT)
  • No prior extensive radiotherapy, defined by any of the following:
  • Prior total body irradiation
  • Prior radiotherapy dose of 3,600 cGy or more to cranio-spinal axis
  • +39 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Dendritic Cell Sarcoma, InterdigitatingBurkitt LymphomaRecurrence

Interventions

RituximabIndiumibritumomab tiuxetanPeripheral Blood Stem Cell TransplantationFilgrastimGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMetals, HeavyElementsInorganic ChemicalsMetalsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Study Officials

  • Mitchell Cairo

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

June 1, 2002

Primary Completion

March 1, 2005

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)