Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Vorinostat in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CCC-PHII-63 6963, NCI-6963, NCT00253630

Objectives

Primary

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

Entry 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

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

Patient Characteristics:

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

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

Outcomes

Response rate (complete response and partial response)

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.

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.

Trial Contact Information

Trial Lead Organizations

California Cancer Consortium

Mark Kirschbaum, MD, Protocol chair		Ph: 626-359-8111 ext. 62830; 800-826-4673 Email: mkirschbaum@coh.org

Registry Information
Official Title		A Phase II Study Suberoylanilide Hydroxamic Acid (SAHA) in Indolent Non-Hodgkin's Lymphoma
Trial Start Date		2005-09-28
Trial Completion Date		2007-02-05 (estimated)
Registered in ClinicalTrials.gov		NCT00253630
Date Submitted to PDQ		2005-09-12
Information Last Verified		2008-10-23
NCI Grant/Contract Number		CM17101, CA33572

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