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

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ClinicalTrials.gov Identifier: NCT00860171
Recruitment Status : Terminated (Terminated due to lack of funding)
First Posted : March 12, 2009
Results First Posted : October 12, 2017
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE March 11, 2009
First Posted Date  ICMJE March 12, 2009
Results First Submitted Date  ICMJE October 7, 2016
Results First Posted Date  ICMJE October 12, 2017
Last Update Posted Date April 3, 2020
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant [ Time Frame: Within 30 days post-transplant ]
    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. The MTD is estimated to be the dose that is associated with a toxicity rate of 25% (Bearman grade 3-4).
  • I-131 Activity Administered [ Time Frame: At time of I-131 therapy ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
  • Maximum tolerated dose of iodine I 131 monoclonal antibody BC8
  • Toxicity at day 30
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Adverse Events [ Time Frame: Up to 6 years ]
    Descriptive statistics will be calculated. DLT will be defined by the Bearman Scale that is designed to address the specific toxicities associated with transplantation.
  • Overall Survival [ Time Frame: Up to 6 years ]
  • Progression-free Survival [ Time Frame: Up to 6 years ]
    number of people with progression free survival
  • Relapse Rate [ Time Frame: Up to 6 years ]
    Number of relapse
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
  • Number and percent of toxicities and responses
  • Overall and progression-free survival rates
  • Relapse rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
Official Title  ICMJE A Study Evaluating Escalating Doses of 131I-BC8 (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies
Brief Summary This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given before autologous stem cell transplant in treating patients with Hodgkin lymphoma or non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment. 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.
Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the maximally tolerated dose of 131I-BC8 (anti-cluster of differentiation [CD]45) (iodine I 131 monoclonal antibody BC8) that can be delivered prior to autologous stem cell transplantation for patients with relapsed/refractory B-non-Hodgkin lymphoma (NHL), T-NHL, or Hodgkin lymphoma (HL).

SECONDARY OBJECTIVES:

I. To optimize the protein dose (antibody [Ab]) to deliver a favorable biodistribution in the majority of patients.

II. To assess the radiation dose delivered to tumor sites and normal organs by the above therapy.

III. To evaluate the dose-response relationship of radiation-dose to tumor and clinical response.

IV. To estimate the overall and progression-free survival of the above regimen in such patients.

V. To evaluate the toxicity and tolerability of the above therapy.

VI. To evaluate the feasibility of delivering high-dose 131I-BC8 and autologous stem cell transplantation (ASCT) to B-Cell NHL, T-NHL, and HL patients.

VII. To evaluate the ability to reduce infusion reactions via unlabeled BC8 preinfusion.

OUTLINE: This is a dose-escalation study.

Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 intravenously (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.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months and then annually thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
A single site, open label clinical trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Recurrent T-Cell Non-Hodgkin Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma
  • Refractory T-Cell Non-Hodgkin Lymphoma
Intervention  ICMJE
  • Procedure: Autologous Hematopoietic Stem Cell Transplantation
    Autologous stem cells given via central catheter
    Other Name: Autologous Stem Cell Transplantation
  • 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
    • MOAB BC8, iodine I 131
    • monoclonal antibody BC8, iodine I 131
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (iodine I 131 monoclonal antibody B, 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.
Interventions:
  • Procedure: Autologous Hematopoietic Stem Cell Transplantation
  • Radiation: Iodine I 131 Monoclonal Antibody BC8
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 19, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2009)
40
Actual Study Completion Date  ICMJE March 21, 2020
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; CD45 antigen expression must be documented on tumor specimens in all cases except HL, in whom histologic demonstration of CD45+ cells adjacent to the Reed Sternberg cells is required
  • Patients must have received at least one prior standard systemic therapy with documented recurrent or refractory disease
  • Mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may be enrolled/transplanted in complete remission (CR)/first partial remission (PR1)
  • Patients are preferred to have either a tumor mass amenable to core needle biopsy during the dosimetry phase, or a measurable tumor mass with at least one site of involvement measuring 2.0 cm in largest dimension on computed tomography (CT) imaging for purposes of planar and/or single-photon emission CT (SPECT)/CT tumor dosimetry (patients with disease that does not allow tumor dosimetry will be allowed on study since they still can contribute toward achieving the primary endpoint, but these patients will be given a lower priority over those with evaluable disease)
  • Creatinine [Cr] < 2.0
  • Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dL
  • All patients eligible for therapeutic study must have a minimum of >= 4 x10^6 CD34/kg autologous hematopoietic stem cells harvested and cryopreserved and divided into 2 aliquots of at least >= 2 x10^6 CD34/kg each; patients with a history of prior autologous hematopoietic cell transplant (HCT) are only required to have >= 2x10^6 CD34/kg stored
  • Patients must have an expected survival of > 60 days and must be free of major infection

Exclusion Criteria:

  • Circulating human anti-mouse antibody (HAMA), to be determined before each infusion
  • Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximab
  • Inability to understand or give an informed consent
  • Lymphoma involving the central nervous system
  • Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g. abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide (DLCO) < 50% predicted, forced expiratory volume in one second (FEV1) < 70% predicted, acquired immune deficiency syndrome [AIDS], etc.)
  • Known human immunodeficiency virus (HIV) seropositivity
  • Pregnancy or breast feeding
  • Prior allogeneic bone marrow or stem cell transplant
  • Prior autologous bone marrow or stem cell transplant or prior radiation therapy (RT) > 20 Gy to a critical organ within 1 year of enrollment
  • Presence of circulating lymphoma cells by morphology or flow cytometry (> 0.1%) at or near the time of peripheral blood stem cell (PBSC) collection if unpurged/unselected PBSC are to be used (patients with cryopreserved stem cells which are negative [=< 0.1% involved] by flow cytometry will also be considered eligible)
  • Southwest Oncology Group (SWOG) performance status >= 2.0
  • Unable to perform self-care during radiation isolation
  • Expected survival if untreated less than 60 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00860171
Other Study ID Numbers  ICMJE 2238.00
NCI-2010-00128 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2238.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P01CA044991 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Ajay Gopal Fred Hutch/University of Washington Cancer Consortium
PRS Account Fred Hutchinson Cancer Research Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP