S0517 Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00132028

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Drug: vorinostat	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Suberoylanilide Hydroxamic Acid for Recurrent or Primary Refractory Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Response rates (complete, complete unconfirmed, and partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival at 1 year [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity profile every 6 months [ Designated as safety issue: Yes ]

Estimated Enrollment:	35
Study Start Date:	September 2005
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132028

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Mark H. Kirschbaum, MD	Beckman Research Institute
Study Chair:	Jasmine M. Zain, MD	Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurence Baker, D.O., SWOG
ClinicalTrials.gov Identifier:	NCT00132028 History of Changes
Other Study ID Numbers:	CDR0000438779, U10CA032102, S0517
Study First Received:	August 16, 2005
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:

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

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012