Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Mark H. Kirschbaum

Study Chair

Jasmine M. Zain

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00132028
Information obtained from ClinicalTrials.gov on December 14, 2011

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