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Bortezomib, Ifosfamide, and Vinorelbine Tartrate in Treating Young Patients With Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Therapy

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ClinicalTrials.gov Identifier: NCT00381940
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : April 10, 2014
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Lymphocyte Predominant Hodgkin Lymphoma
Adult Mixed Cellularity Hodgkin Lymphoma
Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
Adult Nodular Sclerosis Hodgkin Lymphoma
Childhood Lymphocyte Depletion Hodgkin Lymphoma
Childhood Lymphocyte Predominant Hodgkin Lymphoma
Childhood Mixed Cellularity Hodgkin Lymphoma
Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
Childhood Nodular Sclerosis Hodgkin Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent/Refractory Childhood Hodgkin Lymphoma
Stage I Adult Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Adult Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Interventions: Drug: ifosfamide
Drug: bortezomib
Drug: vinorelbine tartrate
Biological: filgrastim

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Ifosfamide, Vinorelbine, Bortezomib)

This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.

ifosfamide: Given IV

bortezomib: Given IV

vinorelbine ditartrate: Given IV

filgrastim: Given IV or SC


Participant Flow:   Overall Study
    Treatment (Ifosfamide, Vinorelbine, Bortezomib)
STARTED   26 
COMPLETED   21 
NOT COMPLETED   5 
Lack of Efficacy                3 
Protocol Violation                1 
Ineligible                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Ifosfamide, Vinorelbine, Bortezomib)

This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.

ifosfamide: Given IV

bortezomib: Given IV

vinorelbine ditartrate: Given IV

filgrastim: Given IV or SC


Baseline Measures
   Treatment (Ifosfamide, Vinorelbine, Bortezomib) 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.9  (2.6) 
Age 
[Units: Participants]
 
<=18 years   23 
Between 18 and 65 years   3 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   12 
Male   14 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   2 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   4 
White   18 
More than one race   0 
Unknown or Not Reported   2 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   4 
Not Hispanic or Latino   22 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   23 
Australia   1 
Canada   2 


  Outcome Measures

1.  Primary:   Complete Response (CR)   [ Time Frame: After 2 cycles of treatment ]

2.  Secondary:   Toxicity   [ Time Frame: 4 weeks following completion of therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Overall Response Rate   [ Time Frame: After 2 cycles and 4 cycles ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Induction Success Rate   [ Time Frame: After 2 cycles and 4 cycles ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Rate of Successful PBSC Harvest   [ Time Frame: After 2 cycles ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Biological Markers   [ Time Frame: Before, during, and after treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 352-273-0567
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00381940     History of Changes
Obsolete Identifiers: NCT01648439
Other Study ID Numbers: NCI-2009-01063
NCI-2009-01063 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000500142
AHOD0521 ( Other Identifier: Children's Oncology Group )
AHOD0521 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: January 8, 2014
Results First Posted: April 10, 2014
Last Update Posted: June 20, 2014