Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma

Part of paid clinical trials in Arcadia, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00036855
Phase
PHASE1
Status
Terminated

Conditions

  • AIDS-related Peripheral/Systemic Lymphoma
  • AIDS-related Primary CNS Lymphoma
  • Post-transplant Lymphoproliferative Disorder
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent/Refractory Childhood Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    Given IV
  • indium In 111 ibritumomab tiuxetan — RADIATION
    Given IV
  • yttrium Y 90 ibritumomab tiuxetan — RADIATION
    Given IV
  • peripheral blood stem cell transplantation — PROCEDURE
    Undergo PBSC transplantation
  • filgrastim — BIOLOGICAL
    Given subcutaneously
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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

Key Dates

Start date
Jun 30, 2002
Status verified
Jan 2013
Primary completion
Mar 31, 2005

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (no planned PBSC support)
    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.
  • Experimental: Group B (planned PBSC support)
    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.

Primary Outcome Measure

MTD, defined as that dose at which fewer than one-third of patients experience DLT graded according to the NCI CTC v 2.0 [ Time Frame: Up to day 49 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Oncology GroupArcadiaCalifornia91006-3776-

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By research site
Children's Oncology Group· Arcadia, CA

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