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Suberoylanilide Hydroxamic Acid in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00124631
  Purpose

RATIONALE: Suberoylanilide hydroxamic acid 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 suberoylanilide hydroxamic acid works in treating patients with relapsed B-cell non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: vorinostat
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Suberoylanilide hydroxamic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response as assessed by positron emission tomography with fludeoxyglucose (FDG-PET) and the International Workshop Standardized Criteria for Non-Hodgkin's lymphoma [ Designated as safety issue: No ]
  • Measurability of tumor lesions as assessed by FDG-PET and CT scan at baseline [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of overall response [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Time to response [ Designated as safety issue: No ]
  • PFS rate at 3 and 6 months [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor effectiveness of suberoylanilide hydroxamic acid, as measured by overall objective response rate, in patients with relapsed diffuse large B-cell lymphoma.

Secondary

  • Determine the duration of response and time to response in patients treated with this drug.
  • Determine progression-free survival, time to progression, and 3- and 6-month progression-free survival rates in patients treated with this drug.
  • Determine the safety of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 4 weeks and then every 6-12 months thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed diffuse large B-cell lymphoma

    • De novo or transformed* disease NOTE: *Patients with transformed diffuse large B-cell lymphoma must meet WHO criteria for diffuse large cell lymphoma on last biopsy prior to study entry AND have ≥ 1 prior histological diagnosis of follicular disease
  • Relapsed disease, defined as recurrent or progressive disease after standard first-line chemotherapy (e.g., CHOP or an anthracycline-containing regimen equivalent) AND 1 systemic salvage therapy that may have included autologous stem cell transplantation

    • Patients who are not candidates for systemic salvage and/or stem cell transplantation are eligible
  • Must have had a response that lasted ≥ 3 months OR stable disease that lasted ≥ 3 months after completion of the most recent treatment
  • Failed no more than 3 prior treatment regimens

    • Pre-induction chemotherapy and autologous stem cell transplantation are considered 1 therapy
    • Antibody therapy (e.g., rituximab) given in combination with or as consolidation therapy after a chemotherapy regimen (without intervening relapse) is considered 1 therapy
    • Antibody therapy given as a single agent is considered 1 therapy
  • Measurable disease, defined as 1 unidimensionally measurable lesion ≥ 2 cm by conventional CT scan OR ≥ 1 cm by spiral CT scan
  • No active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or CT scan or MRI

    • Previously treated CNS disease allowed provided there is negative cytology from lumbar puncture
  • No known HIV-related malignancy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if liver is involved by tumor)
  • No active hepatitis B or C infection

Renal

  • Not specified

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Immunologic

  • No acute infection requiring IV antibiotics or antiviral or antifungal agents within the past 2 weeks
  • No ongoing or active infection
  • No known HIV positivity
  • No known allergy to any component of the study drug
  • No acute or chronic graft-vs-host disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception during and for 14 days after completion of study treatment
  • No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No circumstance that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 4 weeks since prior biologic therapy
  • No prior allogeneic stem cell transplantation
  • No concurrent prophylactic growth factors
  • No concurrent anticancer biologic therapy

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • Concurrent systemic steroids allowed provided the dosage has been stabilized to the equivalent of ≤ 10 mg/day of prednisone for ≥ 4 weeks prior to study entry

Radiotherapy

  • At least 4 weeks since prior radiotherapy
  • No concurrent anticancer radiotherapy

Surgery

  • At least 4 weeks since prior major surgery
  • No prior gastrointestinal resection or procedure that may affect drug absorption

Other

  • Recovered from prior therapy
  • At least 4 weeks since prior investigational therapy
  • No prior histone deacetylase inhibitors (e.g., FR901228, MS-275, or LAQ-824)
  • No concurrent vitamins except a single daily multivitamin
  • No other concurrent investigational anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124631

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Sven De Vos, MD Jonsson Comprehensive Cancer Center
  More Information

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

Study ID Numbers: CDR0000437056, UCLA-0411065-01, MERCK-013-00
Study First Received: July 26, 2005
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00124631  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma

Study placed in the following topic categories:
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
B-cell lymphomas
Vorinostat
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Recurrence

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009