Bortezomib, Ifosfamide, and Vinorelbine Tartrate in Treating Young Patients With Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Therapy
Completed · Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT00381940
- Run by
- National Cancer Institute (NCI)
- People needed
- 26
- Starts
- 2007-01-01
- Expected to finish
- 2016-12-31
- Last updated by the study team
- 2021-03-24
Who can join
Age: any, up to 29. Sex: any. Healthy volunteers: not accepted.
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
- NS, LD
- Not otherwise specified
- Primary refractory disease OR disease in first relapse, except for the following:
- Patients who achieved a complete response after treatment on protocol COG-AHOD0431 who experience a biopsy-proven recurrence after doxorubicin hydrochloride, vincristine, prednisone, and cyclophosphamide without involved-field radiotherapy
- Patients on the observation-only arm of protocol COG-AHOD0431
- Any measurable, focal mass lesion of a visceral organ (e.g., liver, spleen, or kidney)
- Patients with metastatic disease to bone marrow and granulocytopenia, anemia, and/or thrombocytopenia are allowed provided both of the following criteria are met:
- Platelet count ≥ 20,000/mm³ (platelet transfusion allowed)
- Hemoglobin ≥ 8 g/dL (packed red blood cell transfusion allowed)
- Karnofsky performance status (PS) 60-100% (for patients > 16 years of age) OR Lanksy PS 60-100% (for patients =< 16 years of age)
Where it is running
- Children's Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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