Suberoylanilide Hydroxamic Acid in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00124631
First received: July 26, 2005
Last updated: May 23, 2008
Last verified: January 2007
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Resource links provided by NLM:


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

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013