Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

This study is currently recruiting participants.
Verified July 2012 by Fred Hutchinson Cancer Research Center

First Received on March 11, 2009.  
Last Updated on July 31, 2012  
History of Changes
This Clinical Trial Sponsored By: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00860171
 

Purpose for Clinical Trial

This phase I trial is studying the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given before autologous stem cell transplant in treating patients with relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving iodine I 131 monoclonal antibody BC8 before an autologous stem cell transplant may kill more cancer cells

Condition Study Intervention Clinical Trial Phase
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Testicular Lymphoma
Waldenström Macroglobulinemia
Radiation: iodine I 131 monoclonal antibody BC8
Procedure: autologous hematopoietic stem cell transplantation
Phase 1

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study Evaluating Escalating Doses of 131I-BC8 (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Drug Information available for:
Iodine
Sodium iodide I 131
Iodide

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures For Clinical Trial:

  • Estimation of the maximum tolerated dose of I-131-BC8 that can be delivered prior to transplant [ Time Frame: Within 30 days post-transplant ] [ Designated as safety issue: Yes ]
    Dose escalation/de-escalation will be conducted by the "two-stage" approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity.

Secondary Outcome Measures For Clinical Trial:

  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be calculated.

  • Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be calculated.

  • Relapse rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Summarized using cumulative incidence estimates combining all patients and will be utilized as a rough guide to the potential benefits and toxicities of this therapy, but we will refrain from formal statistical comparisons with regard to efficacy because of the phase I nature of this trial.

  • Incidence of adverse events/toxicity [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Descriptive statistics will be calculated. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Dose-limiting toxicity will be defined by the Bearman Scale that is designed to address the specific toxicities associated with transplantation.

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Treatment (monoclonal antibody, autologous HCT)

Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.
Radiation: iodine I 131 monoclonal antibody BC8

Given IV
Other Names:
  • I 131 MOAB BC8
  • I 131 Monoclonal Antibody BC8
  • iodine I 131 MOAB BC8

Procedure: autologous hematopoietic stem cell transplantation

Autologous stem cells given via central catheter

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