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

Condition(s) targeted: Lymphoma

Intervention: vorinostat (Drug); chemotherapy (Procedure); enzyme inhibitor therapy (Procedure)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Mark H. Kirschbaum, MD, Study Chair, Affiliation: Beckman Research Institute
Jasmine M. Zain, MD, Affiliation: Beckman Research Institute

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

Official title: A Phase II Trial of Suberoylanilide Hydroxamic Acid for Recurrent or Primary Refractory Hodgkin's Lymphoma

Study design: Treatment, Open Label

Primary outcome: Response rates (complete, complete unconfirmed, and partial)

Secondary outcome:

Progression-free survival at 1 year

Overall survival

Toxicity profile every 6 months

Detailed description: OBJECTIVES: Primary Determine the response rates (complete, complete unconfirmed, and partial) in patients with relapsed or primary refractory advanced Hodgkin's lymphoma treated with vorinostat (SAHA). Secondary Determine the 1-year progression-free survival and overall survival of patients treated with this drug. Determine the toxicity profile of this drug in these patients. Correlate gene expression profiling of tumor tissue with response in these patients. 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. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 10-18 months.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed Hodgkin's lymphoma Any subtype allowed, including lymphocyte predominant Hodgkin's lymphoma Relapsed or primary refractory disease Advanced disease Clear evidence of disease progression OR lack of response after most recent prior therapy, including local radiotherapy Bidimensionally measurable disease No potentially curative treatment (e. g., salvage therapy with chemotherapy or hematopoietic stem cell transplantation [SCT]) exists No clinical evidence of CNS lymphoma PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic SGOT and SGPT < 2. 5 times upper limit of normal (ULN) Renal Creatinine < 2 times ULN Cardiovascular No myocardial infarction or unstable angina within the past 6 months No stroke within the past 6 months Immunologic No autologous or allogeneic SCT-related active fungal or viral infection No allogeneic SCT-related active acute graft vs host disease (GVHD) of any grade No allogeneic SCT-related chronic GVHD except mild skin, oral, or ocular GVHD not requiring systemic immunosuppression No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug Other Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or stage II cancer in complete remission. PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 months since prior autologous SCT that resulted in disease relapse At least 1 year since prior allogeneic SCT that resulted in disease relapse No concurrent biologic therapy No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) No initiation of epoetin alfa or darbepoetin alfa (Aranesp®) during study treatment Chemotherapy No more than 5 prior chemotherapy regimens At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and recovered Endocrine therapy No concurrent hormonal therapy Radiotherapy See Disease Characteristics At least 14 days since prior radiotherapy and recovered No concurrent radiotherapy Surgery Not specified Other At least 2 weeks since prior valproic acid or other histone deacetylase inhibitors No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent complimentary or alternative medications

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 2005
Last updated: December 25, 2007