NCT00132028

Brief Summary

This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 19, 2012

Completed
Last Updated

May 23, 2014

Status Verified

January 1, 2013

Enrollment Period

3.7 years

First QC Date

August 16, 2005

Results QC Date

February 28, 2012

Last Update Submit

May 7, 2014

Conditions

Adult Favorable Prognosis Hodgkin LymphomaAdult Lymphocyte Depletion Hodgkin LymphomaAdult Lymphocyte Predominant Hodgkin LymphomaAdult Mixed Cellularity Hodgkin LymphomaAdult Nodular Lymphocyte Predominant Hodgkin LymphomaAdult Nodular Sclerosis Hodgkin LymphomaAdult Unfavorable Prognosis Hodgkin LymphomaRecurrent Adult Hodgkin 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.

    after every 3 cycles on treatment

Secondary Outcomes (2)

  • Progression-Free Survival

    after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.

  • Overall Survival

    after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.

Study Arms (1)

Treatment (vorinostat)

EXPERIMENTAL

Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.

Drug: vorinostatOther: laboratory biomarker analysis

Interventions

vorinostatDRUG

Given orally

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Treatment (vorinostat)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (vorinostat)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically or cytologically confirmed relapsed/refractory Hodgkin's lymphoma of any subtype; patients with lymphocyte predominant Hodgkin's disease (LPHD) are also eligible; clear evidence of disease progression or lack of response after the most recent therapy, including local radiation is required
  • Patients must be willing to submit specimens for correlative studies
  • All patients must have bidimensionally measurable disease documented within 28 days prior to registration; patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
  • Patients must have unilateral bone marrow aspirate and biopsy performed within 42 days prior to registration
  • Patients may have had up to five prior chemotherapy regimens
  • Patients must have completed chemotherapy at least 28 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator); if last regimen included nitrosoureas or mitomycin then 42 days must have elapsed since completion of treatment; patients must not have taken valproic acid, or another histone deacetylase inhibitor, for at least 14 days prior to registration
  • Patients must have completed all radiotherapy at least 14 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator)
  • Patients who relapse after autologous stem cell transplant may be enrolled if they are at least three months after transplant, and after allogeneic transplant if they are at least one year posttransplant; patients should have no active related infections (i.e., fungal or viral); in the case of allogeneic transplant relapse, there should be no active acute graft versus host disease (GvHD) of any grade, and no chronic graft versus host disease other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression
  • Patients must have a Zubrod performance status of 0-2
  • Patients must have a CT scan of the chest/abdomen and pelvis performed within 28 days prior to registration
  • Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory or radiographic tests performed to assess CNS involvement must be negative within 42 days of registration
  • Serum LDH must be measured within 28 days prior to registration
  • Absolute neutrophil count \>- 1,000/mcL
  • Platelet count \>= 100,000/mcL
  • SGOT/SGPT \< 2.5 x the institutional upper limit of normal
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Oncology Group (SWOG) Research Base

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Results Point of Contact

Title
Study Statistician
Organization
SWOG Statistical Center
206-667-4623

Study Officials

  • Mark Kirschbaum

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 19, 2005

Study Start

September 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 23, 2014

Results First Posted

September 19, 2012

Record last verified: 2013-01

Locations

US(1)