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

NCT ID: NCT00132028

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-05-31

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the response probability (complete, complete unconfirmed, and partial) in patients with relapsed or refractory Hodgkin's lymphoma.

II. To estimate 1-year progression-free survival and overall survival in patients with relapsed or refractory Hodgkin's lymphoma treated with SAHA.

III. To assess the toxicity profile of SAHA in this patient population. IV. To perform gene expression profiling on tumor tissue before and after treatment in order to explore in a preliminary manner the association between response and specific gene expression results.

OUTLINE: This is a multicenter study.

Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (vorinostat)

Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

vorinostat

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

L-001079038; SAHA; suberoylanilide hydroxamic acid; Zolinza

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Kirschbaum

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

Southwest Oncology Group (SWOG) Research Base

San Antonio, Texas, United States

Countries

United States

Other Identifiers

NCI-2012-03071

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

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S0517

Identifier Type: OTHER

Identifier Source: secondary_id

S0517

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-03071

Identifier Type: -

Identifier Source: org_study_id