Expired Study
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Los Angeles, California 90095


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.


Study summary:

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.


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


NCT ID:

NCT00124631


Primary Contact:

Study Chair
Sven De Vos, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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