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 range

29 Years

Sex

ALL

See this in plain English?

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 \…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Adult Lymphocyte Depletion Hodgkin Lymphoma trials