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Suberoylanilide Hydroxamic Acid in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00124631   Information provided by National Cancer Institute (NCI)
First Received: July 26, 2005   Last Updated: May 23, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

July 26, 2005
May 23, 2008
May 2005
  • 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 ]
  • Objective tumor response as assessed by positron emission tomography with fludeoxyglucose (FDG-PET) and the International Workshop Standardized Criteria for Non-Hodgkin's lymphoma
  • Measurability of tumor lesions as assessed by FDG-PET and CT scan at baseline
Complete list of historical versions of study NCT00124631 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Duration of overall response
  • Progression-free survival (PFS)
  • Time to progression
  • Time to response
  • PFS rate at 3 and 6 months
 
Suberoylanilide Hydroxamic Acid in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

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.

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.

Phase II
Interventional
Treatment, Open Label
Lymphoma
Drug: vorinostat
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
 
 

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
Both
18 Years and older
No
 
United States
 
 
NCT00124631
 
UCLA-0411065-01, MERCK-013-00
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Sven De Vos, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
January 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.