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

Alternate Title

Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	NCI, Pharmaceutical / Industry	CHNMC-07195 07195, MERCK-CHNMC-07195, NCT00720876

Objectives

1. 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.
2. To assess the toxicity profile of this regimen in these patients.

Entry 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

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

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

Expected Enrollment

Outcomes

Response rate (complete and partial response)

Time to progression
Overall survival
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

City of Hope Comprehensive Cancer Center

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

U.S.A.
California
	Beverly Hills
	Tower Cancer Research Foundation
		Solomon Hamburg, MD, PhD	Ph:  310-888-8680
	Duarte
	City of Hope Comprehensive Cancer Center
		Joel Conrad	Ph:  800-826-4673
	South Pasadena
	City of Hope Medical Group
		Mark McNamara, MD	Ph:  626-396-2900
			Email: mmcnamara@ccsmg.com

Registry Information
Official Title		A Phase II Study of Vorinostat (Suberoylanilide Hydroxamic Acid) Plus Rituximab in Indolent Non-Hodgkin's Lymphoma
Trial Start Date		2008-06-05
Trial Completion Date		2011-07-21 (estimated)
Registered in ClinicalTrials.gov		NCT00720876
Date Submitted to PDQ		2008-07-14
Information Last Verified		2009-06-21
NCI Grant/Contract Number		CA33572

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