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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 : Active, not recruiting
First Posted : March 12, 2009
Results First Posted : October 12, 2017
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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
Interventions Procedure: Autologous Hematopoietic Stem Cell Transplantation
Radiation: Iodine I 131 Monoclonal Antibody BC8
Other: Laboratory Biomarker Analysis
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Hide Arm/Group Description

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.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Hide Arm/Group Description

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.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
56.81  (15.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
6
  37.5%
Male
10
  62.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
16
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant
Hide Description 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).
Time Frame Within 30 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Hide Arm/Group Description:

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.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Gray of I-131 (absorbed dose that the I
NA [1] 
[1]
No dose-limiting toxicities observed. Funding ran out, and no MTD identified by the time last patient treated.
2.Primary Outcome
Title I-131 Activity Administered
Hide Description [Not Specified]
Time Frame At time of I-131 therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Hide Arm/Group Description:

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.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 16
Mean (Full Range)
Unit of Measure: mCi I-131
668.15
(344 to 1064)
3.Secondary Outcome
Title Adverse Events
Hide Description Descriptive statistics will be calculated. DLT will be defined by the Bearman Scale that is designed to address the specific toxicities associated with transplantation.
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Hide Arm/Group Description:

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.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: number of adverse events
0
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Hide Arm/Group Description:

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.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: days
1057  (633.59)
5.Secondary Outcome
Title Progression-free Survival
Hide Description Kaplan-Meier estimates will be calculated.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Relapse Rate
Hide Description 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 no formal statistical comparisons with regard to efficacy will be made because of the phase I nature of this trial.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Hide Arm/Group Description

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.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Affected / at Risk (%) # Events
Total   3/16 (18.75%)    
Gastrointestinal disorders   
Mucositis/stomatitis   1/16 (6.25%)  1
General disorders   
Fever  [1]  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
dyspnea   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
[1]
non-neutropenic fever
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
This protocol was closed to enrollment when replaced by a newer approach.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ajay K. Gopal, MD
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-288-2037
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00860171     History of Changes
Other Study ID Numbers: 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 )
First Submitted: March 11, 2009
First Posted: March 12, 2009
Results First Submitted: October 7, 2016
Results First Posted: October 12, 2017
Last Update Posted: November 20, 2018