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

Original Study ID : CDR0000600989

Secondary ID : Array

NCT ID : NCT00720876

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

Official Title : A Phase II Study of Vorinostat (Suberoylanilide Hydroxamic Acid) Plus Rituximab in Indolent Non-Hodgkin's Lymphoma

Brief 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.

Source : National Cancer Institute (NCI)

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.

Overall Status : Recruiting

Start Date : June 2008

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Open Label

Enrollment : 33

Verification Date : December 2008

First Received Date : July 22, 2008

Trial 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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : City of Hope Comprehensive Cancer Center

Status : Recruiting

City : Duarte

State : California

Zip Code : 91010-3000

Country : United States

Facility Name : City of Hope Medical Group

Status : Recruiting

City : Pasadena

State : California

Zip Code : 91105

Country : United States

Facility Name : Tower Cancer Research Foundation

Status : Recruiting

City : Beverly Hills

State : California

Zip Code : 90211

Country : United States

OutComes

Primary OutComes

Measure : Response rate (complete and partial response)

Safety issue : No

Secondary OutComes

Measure : Time to progression

Safety issue : No

Measure : Overall survival

Safety issue : No

Measure : Toxicity

Safety issue : Yes

Interventions

Type : Biological

Name : rituximab

Type : Drug

Name : vorinostat

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