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Clinical Trial Name - Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma
| Original Study ID : CDR0000438779 |
| Secondary ID : SWOG-S0517 |
| NCT ID : NCT00132028 |
| Brief Title : Vorinostat 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 |
| Brief Summary : 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. |
| Source : National Cancer Institute (NCI) |
| 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. |
| Overall Status : Active, not recruiting |
| Start Date : September 2005 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Open Label |
| Enrollment : 35 |
| Verification Date : November 2006 |
| First Received Date : August 16, 2005 |
| Trial Eligibility |
| 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| OutComes |
| Primary OutComes |
| Measure : Response rates (complete, complete unconfirmed, and partial) |
| Safety issue : No |
| Secondary OutComes |
| Measure : Progression-free survival at 1 year |
| Safety issue : No |
| Measure : Overall survival |
| Safety issue : No |
| Measure : Toxicity profile every 6 months |
| Safety issue : Yes |
| Interventions |
| Type : Drug |
| Name : vorinostat |
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