SWOG clinical trial number
S0517

A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma -

Closed
Phase
Accrual
77%
Published
Abbreviated Title
HODGKIN'S: SAHA for Recurrent or Primary Refractory Hodgkin's Lymphoma
Activated
09/15/2005
Closed
08/01/2007
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Lymphoma

Treatment

Suberoylanilide Hydroxamic Acid (SAHA; Vorinostat)

Eligibility Criteria Expand/Collapse

Must have histologically or cytologically confirmed relapsed/refractory Hodgkin's lymphoma or any subtype (lymphocyte predominant Hodgkin's disase are also eligible); clear evidence of disease progression or lack of response after the most recent therapy, including local radiation is required; must be willing to submit specimens for correlative studies as detailed in Section 15.0; must have bidimensionally measurable disease documented w/in 28 days prior to registration; non-measurable disease must be assessed w/in 42 days prior to registration; must have unilateral bone marrow aspirate and biopsy performed w/in 42 days prior to registration; patients may have had up to 5 prior chemotherapy regimens; must have completed chemotherapy at least 28 days prior to registration; if last regimen included nitrosureas or mitomycin then 42 days must have elapsed since completion of treatment; must not have taken valproic acid, or another histone deacetylase inhibitor, for at least 14 days prior to registration; must have completed all RT at least 14 days prior to registration; must be >= age 18; PS=0-2; patients may be enrolled who relapse after autologous stem cell transplant if they are at least 3 months after transplant, and after allogeneic transplant if they are at least 1 year post-transplant; patients should not have any active related infections (i.e. fungal or viral); must have a CT scan or the chest/abdomen and pelvis performed w/in 28 days prior to registration; must not have clinical evidence of CNS involvement by lymphoma; laboratory or radiographic tests performed to assess CNS involvement must be negative w/in 42 days prior to registration; serum LDH must be measured w/in 28 days prior to registration; ANC >= 1,000/mcL, platelets >= 100,000/mcL, SGOT/SGPT < 2.5 x IULN; serum creatinine < 2 x IULN; must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA; must not have plans to receive concurrent hormonal, biological, or radiation therapy; patients must not have potentially curative options such as salvage therapy with chemotherapy or HSCT; must not have a history of prior myocardial infarction, unstable angina, or stroke w/in 6 months; must not be HIV+; must not be pregnant or nursing; patients of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; no prior malignancy is allowed except for the following: adequately treated basal cell cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from the the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years.

Publication Information Expand/Collapse

2012

A phase 2 study of vorinostat for treatment of relapsed or refractory hodgkin lymphoma: SWOG S0517

M Kirschbaum;B Goldman;J Zain;JR Cook;L Rimsza;S Forman;R Fisher Leukemia & Lymphoma 53(2):259-262

PMid: PMID21823829 | PMC number: PMC3477846

2007

Vorinostat (suberoylanilide hydroxamic acid) in relapsed or refractory Hodgkin lymphoma: SWOG 0517

MH Kirschbaum;BH Goldman;JM Zain;JR Cook;LM Rimsza;SJ Forman;RI Fisher Blood 110(11):#2574