Brief Summary

This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach

1 country

123 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.6 years study duration

Study Start

First participant enrolled

January 1, 2006

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed

2.1 years until next milestone

Results Posted

Study results publicly available

September 19, 2012

Completed

Last Updated

May 12, 2014

Status Verified

April 1, 2013

Enrollment Period

4 years

First QC Date

March 15, 2006

Results QC Date

February 28, 2012

Last Update Submit

April 23, 2014

Conditions

Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
assessed at week 8, and every 3 months for 3 years

Secondary Outcomes (2)

Overall Survival
assessed every 3 months for 3 years
Progression-free Survival
assessed at week 8, then every 3 months for 3 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients will receive an infusion of PXD101 once a day for 5 days. Treatment may repeat every 3 weeks for up to 2 years. Some patients will also undergo core biopsy and blood collection for laboratory studies before and after treatment. After finishing treatment, patients will be evaluated every 3-6 months for up to 3 years.

Drug: belinostat

Interventions

belinostatDRUG

Given IV

Also known as: PXD101

Arm I

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Biopsy-proven (no needle aspirations or cytologies) aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following histology subtypes:
Diffuse large cell NHL
Burkitt's or Burkitt-like NHL
Primary mediastinal NHL
Relapsed or refractory disease
Bidimensionally measurable disease
Transformed NHL allowed
Not eligible for stem cell transplantation (for patients registered to study at first relapse)
No active CNS involvement by lymphoma
Zubrod performance status 0-2
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
Absolute neutrophil count \>= 1,500/mm\^3
Platelet count\>=100,000/mm\^3
WBC \>= 3,000/mm\^3
Creatinine \< 2 times upper limit of normal (ULN) OR creatinine clearance \>= 60 mL/min
+29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (123)

Providence Hospital

Mobile, Alabama, 36608, United States

Location

University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, 72401, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Eden Hospital Medical Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants-Fremont

Fremont, California, 94538, United States

Location

Marin General Hospital

Greenbrae, California, 94904, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus