CompletedPhase 2

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

United States26 participantsStarted 2007-01

Plain-language 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.

Who can participate

Age range29 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) * Life expectancy \…

What they're measuring

Complete Response (CR)

Timeframe: After 2 cycles of treatment

Trial details

NCT IDNCT00381940

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2008-06

Results submitted2014-01-08