Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

City of Hope Comprehensive Cancer Center

Robert Chen, MD

Principal Investigator

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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00720876
Information obtained from ClinicalTrials.gov on January 05, 2012

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