Trial record 5 of 5 for:    "Subcutaneous panniculitis-like T-cell lymphoma"

Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00810576
First received: December 16, 2008
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Primary Objectives:

  1. To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib
  2. To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL.

Secondary Objectives:

  1. To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib.
  2. Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.

Condition Intervention Phase
Lymphoma
Drug: Vorinostat
Drug: Bortezomib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study To Determine The Safety and Efficacy Of The Combination of Vorinostat and Bortezomib In Patients With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients With Response [ Time Frame: Every two 21-day cycles ] [ Designated as safety issue: Yes ]
    Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.


Enrollment: 1
Study Start Date: January 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vorinostat + Bortezomib
Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenous (IV) on Days 1, 4, 8, 11.
Drug: Vorinostat
Dose of 200 mg by mouth twice daily on days 1-14 of each 21-day study.
Other Names:
  • SAHA
  • Suberoylanilide Hydroxamic Acid
  • MSK-390
  • Zolinza
Drug: Bortezomib
Dose of 1.3 mg/m^2 by vein on days 1, 4, 8, and 11 of a 21 day cycle.
Other Names:
  • Velcade
  • LDP-341
  • MLN341
  • PS-341

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have an established diagnosis of relapsed or refractory T-cell NHL Eligible histologies include; Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma ( ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, angiocentric/nasal type T/NK-cell lymphoma, intestinal T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma, transformed Mycosis fungoides; All patients must have had at last one prior system regimen (radiation therapy does not qualify as systemic treatment).
  2. Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk: A minimum of two cycles of therapy will be given before crossing over to transplant.
  3. Patients must have at least one clear-cut bi-dimensionally measurable site by physical exam and/or computed tomography: Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within four weeks prior to registration of this study.
  4. Patient may have had prior radiation therapy for localized disease: Therapy must be completed at last four weeks before the enrollment in the study.
  5. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  6. Patients must be age 18 years old and above.
  7. Patients are required to have adequate bone marrow reserve as indicated: Absolute neutrophil count (ANC) >/= 1000/mm^3; Platelets >/= 80,000/mm^3; Hemoglobin >/= 8g/dL; If there is bone marrow involvement by lymphoma then there is no minimum level of counts required; These values must be obtained within two weeks before protocol entry.
  8. Patients must have adequate liver function as indicated by:Bilirubin </= 1.5 times the upper limit of normal (ULN); Alanine transaminase (ALT) </= 2 times the (ULN) or aspartate transaminase (AST) </= 2 times the ULN; These values must be obtained within two weeks before protocol entry.
  9. Patients are required to have adequate renal function as indicated by a serum creatinine </= 2.5 mg/dL; This value must be obtained within two weeks before protocol entry.
  10. Male patients must agree to use an accepted and effective method of contraception for the duration of the study.
  11. Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
  12. Female patients of childbearing potential must have a negative serum pregnancy test (Beta hCG) within 72 hours of receiving the first dose of vorinostat.
  13. Patients must have the ability able to give informed consent.

Exclusion Criteria:

  1. Patients with: T-cell lymphoma with skin involvement only are excluded if they have no evidence of systemic disease; T-cell prolymphocytic leukemia (T-PLL); T-cell large granular lymphocytic leukemia; Primary cutaneous CD30+ disorders: anaplastic large cell lymphoma and lymphomatoid papulosis
  2. Patients with active Hepatitis B and/or Hepatitis C infection.
  3. Patients with known HIV infection are excluded: These patients are excluded secondary to potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy.
  4. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
  5. Patients with left ventricular ejection fraction (LVEF) < 45%.
  6. Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: Congestive heart failure; Severe CAD; Cardiomyopathy; Uncontrolled cardiac arrhythmia; Unstable angina pectoris; Recent MI.
  7. Patients with prior exposure to either vorinostat (including other HDAC inhibitors except valproic acid) or bortezomib: Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment.
  8. Patients who are pregnant or breast-feeding: Effects of this treatment on the fetus and young children are unknown at this time.
  9. Patients who have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast who is currently without evidence of disease.
  10. Patients undergoing anti-neoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within the past four weeks. Receipt of systemic corticosteroids within 7 days of study treatment unless patient has been taking a continuous dose of no more than 10 mg/day of prednisone for at least 1 month.
  11. Patients with deep vein thrombosis within three months.
  12. Patients with lymphoma involvement of the CNS.
  13. Patients who have undergone prior allogenic transplantation: Prior autologous transplantation is accepted.
  14. Patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and anti-tumor activity of vorinostat and/or bortezomib.
  15. Patient with a history of allergic reaction attributable to compounds containing boron or mannitol.
  16. Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
  17. Patients with grade 2 or more neuropathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810576

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Barbara Pro, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00810576     History of Changes
Other Study ID Numbers: 2007-0658
Study First Received: December 16, 2008
Results First Received: June 11, 2010
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Subcutaneous panniculitic T-cell lymphoma
Relapsed T-Cell Non-Hodgkin's Lymphoma
Refractory T-Cell Non-Hodgkin's Lymphoma
NHL
T-cell NHL
vorinostat
SAHA
Suberoylanilide Hydroxamic Acid
MSK-390
Zolinza
Bortezomib
Velcade
LDP-341
MLN341
PS-341
Peripheral T-cell lymphoma
CD 30 + anaplastic large cell lymphoma
Angioimmunoblastic T-cell lymphoma
Angiocentric/nasal type T/NK-cell lymphoma
Intestinal T-cell lymphoma
Hepatosplenic gamma delta T-cell lymphoma
Transformed Mycosis fungoides

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vorinostat
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014