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Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma
This study is currently recruiting participants.
Verified January 2012 by City of Hope Medical Center

First Received on July 22, 2008.   Last Updated on January 4, 2012   History of Changes
Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Merck
Information provided by (Responsible Party): City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00720876
  Purpose

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving vorinostat together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects of giving vorinostat together with rituximab and to see how well it works in treating patients with indolent non-Hodgkin lymphoma.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: vorinostat
Phase II

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Vorinostat (Suberoylanilide Hydroxamic Acid) Plus Rituximab in Indolent Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Response rate (complete and partial response) [ Time Frame: 1 year after the start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 1 year after the start of treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year after the start of treatment ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 3 weeks after the stop of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Study Start Date: June 2008
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: rituximab
    Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
    Drug: vorinostat
    200 mg twice to three times daily, orally for 14 days followed by a seven day break on a 21 day cycle.
Detailed Description:

OBJECTIVES:

  • To evaluate the anti-tumor activity of vorinostat and rituximab, in terms of objective response rate, time to progression, and survival, in patients with indolent non-Hodgkin lymphoma.
  • To assess the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive oral vorinostat twice daily on days 1-14 and rituximab IV on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

  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 lymphoma, including any of the following subtypes:

    • Grade 1, 2, or 3 follicular center lymphoma
    • Marginal zone B-cell lymphoma (nodal or extranodal)
    • Mantle cell lymphoma
  • Newly diagnosed or relapsed/refractory disease

    • Most recent therapy must have failed to induce a complete response (i.e., persistent disease by CT scan or PET scan) disease progression or recurrence after the most recent therapy (for patients with previously treated disease)
  • Relapsed disease after prior stem cell transplantation allowed
  • Measurable disease by CT scan
  • No known brain metastases

    • Previously treated brain metastases allowed provided they are controlled AND there is no requirement for steroids within the past 2 months

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin normal

    • Elevated unconjugated bilirubin allowed (i.e., Gilbert's disease)
  • AST/ALT ≤ 2.5 times upper limit of normal
  • Creatinine ≤ 2 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would limit compliance with study requirements
  • No HIV positivity
  • No other active malignancies
  • No active, transplant-related infections (i.e., fungal or viral infection)
  • No active acute graft-vs-host disease (GVHD) of any grade
  • No chronic GVHD other than mild skin, oral, or ocular GVHD that does not require systemic immunosuppression

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • More than 2 weeks since prior radiotherapy
  • More than 4 weeks since prior chemotherapy (2 weeks for low-dose chlorambucil; 6 weeks for nitrosoureas or mitomycin C)
  • No more than 4 prior chemotherapy regimens

    • Steroids alone or local radiotherapy are not considered prior regimens
    • Rituximab alone is not considered a prior regimen, but tositumomab (Bexxar) and ibritumomab tiuxetan (Zevalin) are considered prior regimens
  • More than 2 days since prior steroids
  • At least 2 weeks since prior valproic acid
  • At least 3 months since prior autologous stem cell transplantation (SCT)
  • At least 6 months since prior allogeneic SCT
  • No other concurrent hormonal therapy, biological therapy, radiotherapy, or chemotherapy
  • No concurrent complementary and alternative medicine (CAM) therapy

    • Routine vitamin supplementation allowed
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720876

Locations
United States, California
Tower Cancer Research Foundation Recruiting
Beverly Hills, California, United States, 90211
Contact: Solomon I. Hamburg, MD, PhD     310-888-8680        
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Joel Conrad     800-826-4673        
City of Hope Medical Group Recruiting
Pasadena, California, United States, 91105
Contact: Mark V. McNamara, MD     626-396-2900     mmcnamara@ccsmg.com    
Sponsors and Collaborators
City of Hope Medical Center
Merck
Investigators
Principal Investigator: Robert Chen, MD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00720876     History of Changes
Other Study ID Numbers: 07195, P30CA033572, CDR0000600989, NCI-2010-00531
Study First Received: July 22, 2008
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
contiguous stage II marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma
splenic marginal zone lymphoma
stage I marginal zone lymphoma
stage III marginal zone lymphoma
stage IV marginal zone lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
recurrent mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Vorinostat
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012