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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI, Other	CDR0000438779 SWOG-S0517, NCT00132028

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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00132028
Information obtained from ClinicalTrials.gov on December 06, 2009

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