Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma

NCT00958074 | Terminated Phase 2 Results

• 2 other identifiers: 6914NCI-2009-01231
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the side effects and how well vorinostat works in treating patients with primary cutaneous T-cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

Conditions

Cutaneous T-cell Lymphoma Stage I; Cutaneous T-cell Lymphoma Stage II; Cutaneous T-cell Lymphoma Stage III; Cutaneous T-cell Lymphoma Stage IV

Outcome Measures

Primary Outcomes (1)

• Objective Response

  Defined as either no evidence of clinical disease or marked improvement (\>= 50%) decrease in the modified Severity-Weighted Assessment Tool (mSWAT) skin assessment score compared to baseline.

  After at least 14 days. With Confirmation after additional 28 days.

Secondary Outcomes (4)

• Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood);

  Up to 30 days post-treatment

• Occurrences of Dose Adjustment as Measured by Safety/Toxicity

  Up to 30 days post-treatment

• Number of Participants With Overall Response as Measured by Sezary Cell Count

  Baseline to 30 days post-treatment

• Changes in the Physicians Serial Assessment of Erythroderma Score

  Baseline to 30 days post-treatment

Study Arms (2)

Cohort I (>=65 years old)

EXPERIMENTAL

200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.

Drug: vorinostat; Other: flow cytometry; Other: laboratory biomarker analysis

Cohort II (<65 years old)

EXPERIMENTAL

400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.

Drug: vorinostat; Other: flow cytometry; Other: laboratory biomarker analysis

Interventions

vorinostat DRUG

Given PO

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza

Cohort I (>=65 years old); Cohort II (<65 years old)

flow cytometry OTHER

correlative study

Cohort I (>=65 years old); Cohort II (<65 years old)

laboratory biomarker analysis OTHER

correlative study

Cohort I (>=65 years old); Cohort II (<65 years old)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant females
• Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sezary syndrome
• Documentation of diagnosis by histologic examination should be available
• Subjects with CTCL stages IB, IIA, IIB, III, or IVA who have not received any prior systemic therapies
• Anticipated life expectancy greater than 6 months
• Performance status 0, 1, or 2 by Eastern Cooperative Oncology Group (ECOG) criteria
• Written informed consent to participate in the study
• Absolute neutrophil count (ANC) \>= 1,000/mcL
• Platelets \>= 75,000/mcL
• Hemoglobin \>= 9 g/dL
• Prothrombin time or international normalized ratio (INR) =\< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation
• Partial thromboplastin time (PTT) =\< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation
• Serum creatinine =\< 1.5 X ULN OR calculated creatinine clearance \>= 60 mL/min for patients with creatinine levels \> 1.5 X institutional ULN; creatinine clearance should be calculated per institutional standard
• Serum total bilirubin =\< 2 X ULN
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic aminotransaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic aminotransaminase \[SGPT\]) =\< 3.0 X ULN

You may not qualify if:

• Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVB)
• Presence of lymphadenopathy is permitted
• ECOG performance status \> 2
• Concomitant use of any anti-cancer therapy or immune modifier
• Concomitant use of any investigational agent or device
• Concomitant therapy with any other anti-CTCL therapy, or radiation therapy (topical corticosteroids or low dose oral corticosteroids \[=\< 10 mg/day prednisone or equivalent\] will not be excluded, but if used, the dose and schedule must be stable during the two weeks immediately prior to study entry)
• Use of any previous systemic therapy (except single agent targretin), total skin electron beam (TSEB) therapy or extracorporeal photopheresis
• Evidence of clinically significant (uncontrolled) hypo- or hyperthyroidism
• Poorly controlled diabetes mellitus as evidenced by hemoglobin (Hgb)A1c \> 6.5 mg/dl
• Recent (in the past 6 months) medically significant cardiac event (i.e. myocardial infarction, cardiac surgery)
• Presence of congestive heart failure (New York Heart Association \[NYHA\] class IV) or angina (NYHA class IV) or presence of a medically significant arrhythmia
• Congenital long QT syndrome
• Corrected QT interval \> 480 msec on screening electrocardiogram (ECG)
• Presence of uncontrolled hypertension manifested by systolic blood pressure \>= 180 mmHg and/or diastolic blood pressure \>= 100 mmHg
• Documented current active infection with human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, and/or cytomegalovirus (CMV)

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

Vorinostat; Flow Cytometry

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Andrei Shustov
• Organization: University of Washington

ashustov@uw.edu

206-288-6744

Study Officials

• Andrei Shustov

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 13, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 18, 2018
• Results First Posted: December 15, 2014

Record last verified: 2018-09

Locations

US (1)