A Phase II Trial of Suberoylanilide Hydroxamic Acid for Recurrent or Primary Refractory Hodgkin's Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Trial of Suberoylanilide Hydroxamic Acid for Recurrent or Primary Refractory Hodgkin's Lymphoma
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.
Inclusion 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 central nervous system (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
- aspartate aminotransferase (SGOT) / alanine aminotransferase (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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Outcome Description:
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Outcome Time Frame:
after every 3 cycles on treatment
Safety Issue:
No
Principal Investigator
Mark H. Kirschbaum, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-03071
NCT ID:
NCT00132028
Start Date:
September 2005
Completion Date:
July 2011
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- adult lymphocyte depletion Hodgkin lymphoma
- adult lymphocyte predominant Hodgkin lymphoma
- adult mixed cellularity Hodgkin lymphoma
- adult nodular sclerosis Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
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