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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
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Ifosfamide, Vinorelbine, Bortezomib)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 26
Completed 21
Not Completed 5
Reason Not Completed
Lack of Efficacy             3
Protocol Violation             1
Ineligible             1
Arm/Group Title Treatment (Ifosfamide, Vinorelbine, Bortezomib)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
15.9  (2.6)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
23
  88.5%
Between 18 and 65 years
3
  11.5%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
12
  46.2%
Male
14
  53.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  15.4%
White
18
  69.2%
More than one race
0
   0.0%
Unknown or Not Reported
2
   7.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Hispanic or Latino
4
  15.4%
Not Hispanic or Latino
22
  84.6%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
United States 23
Australia 1
Canada 2
1.Primary Outcome
Title Complete Response (CR)
Hide Description CR is defined as at least 80% reduction in the sum of the products of the perpendicular diameters of each of the nodal masses or return to normal size, along with negative nuclear medicine imaging.
Time Frame After 2 cycles of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all patients evaluable for tumor response. Three enrolled patients are excluded: 1 ineligible, 1 who was removed from treatment after 1 dose of bortezomib, and 1 who received only 1/3 dose of bortezomib in cycle 1 and part of cycle 2 due to pharmacy error.
Arm/Group Title Treatment (Ifosfamide, Vinorelbine, Bortezomib)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
With CR 2
Without CR 21
2.Secondary Outcome
Title Toxicity
Hide Description [Not Specified]
Time Frame 4 weeks following completion of therapy
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Response Rate
Hide Description Overall response includes complete response and partial response.
Time Frame After 2 cycles and 4 cycles
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Induction Success Rate
Hide Description Induction success is defined as achieving CR or PR without a targeted primary toxicity.
Time Frame After 2 cycles and 4 cycles
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Rate of Successful PBSC Harvest
Hide Description Success is defined as the ability to harvest 2x10^6 CD34+ cells/kg within 5 collection days.
Time Frame After 2 cycles
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Biological Markers
Hide Description Assessing baseline NF-kB protein levels in tumor tissue
Time Frame Before, during, and after treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description 25 patients reported, 1 ineligible patient not included in adverse events.
 
Arm/Group Title Treatment (Ifosfamide, Vinorelbine, Bortezomib)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Ifosfamide, Vinorelbine, Bortezomib)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Ifosfamide, Vinorelbine, Bortezomib)
Affected / at Risk (%) # Events
Total   4/25 (16.00%)    
Gastrointestinal disorders   
Abdominal pain  1/25 (4.00%)  1
Nausea  1/25 (4.00%)  1
Vomiting  1/25 (4.00%)  1
General disorders   
Fatigue  1/25 (4.00%)  1
Immune system disorders   
Anaphylaxis  1/25 (4.00%)  1
Metabolism and nutrition disorders   
Anorexia  1/25 (4.00%)  1
Dehydration  1/25 (4.00%)  1
Hypokalemia  2/25 (8.00%)  2
Nervous system disorders   
Depressed level of consciousness  1/25 (4.00%)  1
Neuralgia  1/25 (4.00%)  1
Psychiatric disorders   
Depression  1/25 (4.00%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Ifosfamide, Vinorelbine, Bortezomib)
Affected / at Risk (%) # Events
Total   18/25 (72.00%)    
Blood and lymphatic system disorders   
Anemia  4/25 (16.00%)  4
Febrile neutropenia  3/25 (12.00%)  3
Gastrointestinal disorders   
Abdominal pain  1/25 (4.00%)  1
Mucositis oral  1/25 (4.00%)  1
Vomiting  1/25 (4.00%)  1
General disorders   
Death NOS  3/25 (12.00%)  3
Infections and infestations   
Catheter related infection  2/25 (8.00%)  2
Infections and infestations - Other, specify  7/25 (28.00%)  7
Urinary tract infection  1/25 (4.00%)  1
Injury, poisoning and procedural complications   
Vascular access complication  1/25 (4.00%)  1
Investigations   
Activated partial thromboplastin time prolonged  1/25 (4.00%)  1
Alanine aminotransferase increased  2/25 (8.00%)  2
Blood bilirubin increased  1/25 (4.00%)  1
Lymphocyte count decreased  4/25 (16.00%)  4
Neutrophil count decreased  6/25 (24.00%)  6
Platelet count decreased  3/25 (12.00%)  3
White blood cell decreased  5/25 (20.00%)  5
Metabolism and nutrition disorders   
Anorexia  1/25 (4.00%)  1
Hyperglycemia  2/25 (8.00%)  2
Hyperkalemia  1/25 (4.00%)  1
Hypermagnesemia  1/25 (4.00%)  1
Hypocalcemia  1/25 (4.00%)  1
Hypokalemia  3/25 (12.00%)  3
Hypophosphatemia  2/25 (8.00%)  2
Musculoskeletal and connective tissue disorders   
Bone pain  2/25 (8.00%)  2
Nervous system disorders   
Neuralgia  1/25 (4.00%)  1
Peripheral motor neuropathy  1/25 (4.00%)  1
Peripheral sensory neuropathy  2/25 (8.00%)  2
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders - Other, specify  1/25 (4.00%)  1
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.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 352-273-0567
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