Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Adult Favorable Prognosis Hodgkin Lymphoma, 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, Adult Unfavorable Prognosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma

In brief

This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00132028

Run by

National Cancer Institute (NCI)

People needed

27

Starts

2005-09-01

Expected to finish

2009-05-01

Last updated by the study team

2014-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed relapsed/refractory Hodgkin's lymphoma of any subtype; patients with lymphocyte predominant Hodgkin's disease (LPHD) are also eligible; clear evidence of disease progression or lack of response after the most recent therapy, including local radiation is required
• Patients must be willing to submit specimens for correlative studies
• All patients must have bidimensionally measurable disease documented within 28 days prior to registration; patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
• Patients must have unilateral bone marrow aspirate and biopsy performed within 42 days prior to registration
• Patients may have had up to five prior chemotherapy regimens
• Patients must have completed chemotherapy at least 28 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator); if last regimen included nitrosoureas or mitomycin then 42 days must have elapsed since completion of treatment; patients must not have taken valproic acid, or another histone deacetylase inhibitor, for at least 14 days prior to registration
• Patients must have completed all radiotherapy at least 14 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator)
• Patients who relapse after autologous stem cell transplant may be enrolled if they are at least three months after transplant, and after allogeneic transplant if they are at least one year posttransplant; patients should have no active related infections (i.e., fungal or viral); in the case of allogeneic transplant relapse, there should be no active acute graft versus host disease (GvHD) of any grade, and no chronic graft versus host disease other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression
• Patients must have a Zubrod performance status of 0-2
• Patients must have a CT scan of the chest/abdomen and pelvis performed within 28 days prior to registration
• Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory or radiographic tests performed to assess CNS involvement must be negative within 42 days of registration
• Serum LDH must be measured within 28 days prior to registration
• Absolute neutrophil count >- 1,000/mcL
• Platelet count >= 100,000/mcL
• SGOT/SGPT < 2.5 x the institutional upper limit of normal
• Serum creatinine < 2 x the institutional upper limit of normal
• Patients with a history of allergic reactions attributed to compounds of similar chemical or biological composition to SAHA are ineligible
• Patients must not have plans to receive concurrent hormonal, biological or radiation therapy; patients with potentially curative options such as salvage therapy with chemotherapy or hematopoietic stem cell transplant (HSCT) are not eligible
• Patients with a history of prior myocardial infarction, unstable angina, or stroke within 6 months are ineligible
• Patients known to be HIV-positive and receiving combination antiretroviral therapy are ineligible; in addition, HIV-positive patients not receiving combination antiretroviral therapy are also ineligible
• No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for five years
• Pregnant or nursing women may not participate; women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Where it is running

• Southwest Oncology Group (SWOG) Research Base — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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