A Phase II Trial of Suberoylanilide Hydroxamic Acid for Recurrent or Primary Refractory Hodgkin's Lymphoma
- Determine the response rates (complete, complete unconfirmed, and partial) in patients
with relapsed or primary refractory advanced Hodgkin's lymphoma treated with vorinostat
- 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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
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.
after every 3 cycles on treatment
Mark H. Kirschbaum, MD
Beckman Research Institute
United States: Food and Drug Administration