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Vorinostat in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00253630
  Purpose

RATIONALE: Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory indolent 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 Study Suberoylanilide Hydroxamic Acid (SAHA) in Indolent Non-Hodgkin's Lymphoma

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

Primary Outcome Measures:
  • Response rate (complete response and partial response) [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: September 2005
Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the time to disease progression in patients with relapsed or refractory indolent non-Hodgkin's lymphoma treated with vorinostat.
  • Determine the objective response rate in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days for up to a total of 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed indolent non-Hodgkin's lymphoma, including the following subtypes:

    • Grade 1, 2, or 3 follicular lymphoma
    • Marginal zone B-cell lymphoma

      • Nodal or extranodal
    • Mantle cell lymphoma
  • Measurable disease by CT scan
  • Relapsed or refractory disease

    • Disease progression or recurrence after most recent therapy OR failure to induce a complete response after most recent therapy
  • No known brain metastases

    • Previously treated brain metastases that are currently asymptomatic without steroids allowed

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal (patients with elevated unconjugated bilirubin [e.g., Gilbert's disease] allowed)
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine ≤ 2 mg/dL

Cardiovascular

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

Immunologic

  • No known HIV infection
  • No active or ongoing infection
  • No history of allergic reaction to compounds of similar chemical or biologic composition to vorinostat

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • No other active malignancy
  • No active graft-vs-host disease (GVHD)
  • No chronic GVHD except mild skin, oral, or ocular GVHD with no requirement for systemic immunosuppression

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • See Chemotherapy
  • More than 3 months since prior rituximab (unless there is evidence of progression)
  • At least 3 months since prior autologous stem cell transplantation
  • At least 6 months since prior allogeneic stem cell transplantation
  • No concurrent biologic therapy
  • No concurrent sargramostim (GM-CSF) or filgrastim (G-CSF)
  • Concurrent epoetin alfa or darbepoetin alfa therapy for lymphoma-related anemia allowed provided it is initiated before the start of study therapy

Chemotherapy

  • No more than 4 prior chemotherapeutic regimens

    • Steroids alone, rituximab alone, or local radiation is not considered 1 regimen
    • Iodine I 131 tositumomab OR ibritumomab tiuxetan alone is considered 1 regimen
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • At least 2 weeks since prior low-dose chlorambucil
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • See Chemotherapy
  • At least 2 days since prior steroid therapy
  • At least 2 months since prior steroids for the treatment of brain metastases
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • See Chemotherapy
  • More than 2 weeks since prior radiotherapy
  • No concurrent radiotherapy

Other

  • Recovered from prior therapy
  • At least 2 weeks since prior valproic acid
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • No concurrent complementary or alternative medicines except routine vitamin supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253630

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: Mark H. Kirschbaum, MD Beckman Research Institute
  More Information

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

Publications of Results:
Kirschbaum M, Zain J, Popplewell L, et al.: Phase 2 study of suberoylanilide hydroxamic acid (SAHA) in relapsed or refractory indolent non-Hodgkin lymphoma: a California Cancer Consortium study. [Abstract] J Clin Oncol 25 (Suppl 18): A-18515, 703s, 2007.

Study ID Numbers: CDR0000449981, CCC-PHII-63, NCI-6963
Study First Received: November 11, 2005
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00253630  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Vorinostat
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Mantle cell lymphoma
Recurrence
Lymphoma, B-Cell
Lymphatic Diseases
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

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 14, 2009