Suberoylanilide Hydroxamic Acid in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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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) |
- 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 ]
- 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 |
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 |
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| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095 | |
| 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