Bortezomib, Ifosfamide, and Vinorelbine Tartrate in Treating Young Patients With Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Therapy
A Phase II Study of Bortezomib (Velcade, PS-341) in Combination With Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults With Refractory/Recurrent Hodgkin Disease
4 other identifiers
interventional
26
1 country
1
Brief Summary
This phase II trial studies the side effects and efficacy of bortezomib with ifosfamide and vinorelbine in children and young adults with Hodgkin's lymphoma that was recurrent or did not respond to previous therapy. Bortezomib is an inhibitor of protein degradation. Bortezomib degrades short-lived regulatory proteins in the cell, and has been reported to increase the tumor cells. Bortezomib may increase the effectiveness of ifosfamide and vinorelbine (two standard drugs given to children with Hodgkin Lymphoma that has come back after initial treatment) by making cancer cells more sensitive to effectiveness of standard chemotherapy by preventing anti-death responses in these drugs. Giving bortezomib together with ifosfamide and vinorelbine tartrate should kill more cancer cells than are killed with ifosfamide and vinorelbine alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 28, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedResults Posted
Study results publicly available
April 10, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedMarch 24, 2021
March 1, 2021
1.4 years
September 26, 2006
January 8, 2014
March 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Response (CR)
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.
After 2 cycles of treatment
Secondary Outcomes (5)
Number of Participants With Grade 3 or 4 Toxicity
4 weeks following completion of therapy
Overall Response Rate
After 2 cycles and 4 cycles
Induction Success Rate
After 2 cycles and 4 cycles
Rate of Successful PBSC Harvest
After 2 cycles
Biological Markers
Before, during, and after treatment
Study Arms (1)
Treatment (enzyme inhibitor therapy, chemotherapy)
EXPERIMENTALPatients receive ifosfamide IV continuously over days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, bortezomib IV 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 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.
Interventions
Given IV
Given IV
Given IV
Given IV or SC
Eligibility Criteria
You may qualify if:
- Histologically confirmed Hodgkin's lymphoma at time of relapse or disease progression, meeting all of the following criteria:
- Stage I-IV disease
- No morphologically unclassifiable disease
- Meets 1 of the following criteria:
- Mixed cellularity
- Lymphocytic depletion (LD)
- LD, diffuse fibrosis
- LD, reticular
- Lymphocyte predominance (LP)
- LP, diffuse
- LP, nodular
- Nodular sclerosis (NS)
- NS, cellular phase
- NS, lymphocytic predominance
- NS, mixed cellularity
- +36 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Oncology Group
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Horton TM, Drachtman RA, Chen L, Cole PD, McCarten K, Voss S, Guillerman RP, Buxton A, Howard SC, Hogan SM, Sheehan AM, Lopez-Terrada D, Mrazek MD, Agrawal N, Wu MF, Liu H, De Alarcon PA, Trippet TM, Schwartz CL. A phase 2 study of bortezomib in combination with ifosfamide/vinorelbine in paediatric patients and young adults with refractory/recurrent Hodgkin lymphoma: a Children's Oncology Group study. Br J Haematol. 2015 Jul;170(1):118-22. doi: 10.1111/bjh.13388. Epub 2015 Apr 1.
PMID: 25833390DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Terzah Horton
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 28, 2006
Study Start
January 1, 2007
Primary Completion
June 1, 2008
Study Completion
December 31, 2016
Last Updated
March 24, 2021
Results First Posted
April 10, 2014
Record last verified: 2021-03