Cutaneous T-cell Lymphoma Stage IPhase 2NCT00958074
Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma
A Phase 2 study testing vorinostat, flow cytometry and laboratory biomarker analysis in people with Cutaneous T-cell Lymphoma Stage I and Cutaneous T-cell Lymphoma Stage II, run by University of Washington at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-cell Lymphoma Stage I, Cutaneous T-cell Lymphoma Stage II, Cutaneous T-cell Lymphoma Stage III
- What is being tested?
- vorinostat, flow cytometry and laboratory biomarker analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Alkaline Phosphatase (liver fraction) =< 3.0 X ULN
Who cannot join
- 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)
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- 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)
- Presence of uncontrolled bacterial or viral infection (subject may be receiving chronic antimicrobial therapy)
- History of culture-documented bacteremia in the previous 2 weeks
- Concurrent therapy with any histone deacetylase (HDAC)-like compound; patients treated with valproic acid for epilepsy may enroll after a 30 day washout period
- Recent change (in the past 2 weeks) in the doses or regimens of medication used for any chronic non-oncologic conditions for reasons of worsening of chronic illness (change in doses of chronic medications associated with improvement in a chronic illness are not exclusion criteria)
- Presence of any acute or chronic non-oncologic disease which, in the opinion of the investigator, is medically uncontrolled
- History of a prior malignancy with the exception of cervical intraepithelial neoplasia; non-melanoma skin cancer; adequately treated localized prostate carcinoma with prostate specific antigen (PSA) < 1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, and/or who is deemed at low risk for recurrence (< 30% probability) by his/her treating physician
- Patient with a "currently active" second malignancy, other than nonmelanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled
- Any significant medical or psychiatric condition that, in the opinion of the investigator, might prevent the subject from complying with all required study procedures
- Women of childbearing potential must have a pregnancy test within 28 days prior to registration, and must use an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 3 months after the study
- Females of childbearing potential and sexually active males, if indicated, must be willing and able to use two methods of contraception that are adequate to prevent or minimize risk of pregnancy for the duration of the study; one of which must be a barrier method
- Patient has symptomatic ascites or pleural effusion (a patient who is clinically stable following treatment for these conditions is eligible)
- Patient has had allogeneic transplant
- Patient has a history of a gastrointestinal surgery or other procedures that might, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Phase II Prospective Non-Randomized Clinical Trial of Dose-Adjusted Schedule of Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma Who Did Not Receive Prior Systemic Therapy or Have Been Treated With Single Agent Targretin
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
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the objective response rate to treatment with dose-adjusted Vorinostat schedule in subjects with cutaneous T-cell lymphoma (CTCL) who did not receive prior systematic therapy or have been treated with single agent targretin (bexarotene).
SECONDARY OBJECTIVES:
- To determine the safety and tolerability of dose-adjusted Vorinostat schedule when administered to patients with primary cutaneous T-cell lymphoma who did not receive prior systematic therapy or have been treated with single agent targretin.
II. To determine the time to objective response in subjects with CTCL treated with dose-adjusted schedule of Vorinostat as primary therapy.
III To determine the duration of objective response in subjects with CTCL.
IV. To determine the time to loss of objective response.
- To determine the objective response rate of extracutaneous manifestations of CTCL (lymph node enlargement, Sezary cells in peripheral blood).
VI. To compare the efficacy, toxicity and tolerability of dose-adjusted schedule to currently recommended flat dose of Vorinostat in subjects with CTCL.
OUTLINE: Patients are assigned to 1 of 2 treatment arms according to age (< 65 vs >= 65 years old).
COHORT I (>= 65 years old): Patients receive 200 mg vorinostat orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
COHORT II (< 65 years old): Patients receive 400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days.
- 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
- Being tested
- vorinostat, flow cytometry, laboratory biomarker analysis
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vorinostatDrug
Also called L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Given PO
flow cytometryOther
correlative study
laboratory biomarker analysisOther
correlative study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: vorinostat; Other: flow cytometry; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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);
Assessed by changes in the sum of the products in the greatest diameters of enlarged lymph nodes by serial computed tomography (CT) or positron emission tomography (PET)/CT scans.
Measured: Up to 30 days post-treatment
Occurrences of Dose Adjustment as Measured by Safety/Toxicity
Toxicities will be graded in severity according to the guidelines outlined in the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
Measured: Up to 30 days post-treatment
Number of Participants With Overall Response as Measured by Sezary Cell Count
Overall response defined by a clinically significant decrease in Sezary cell count (>50% decrease from baseline).
Measured: Baseline to 30 days post-treatment
Changes in the Physicians Serial Assessment of Erythroderma Score
Measured: Baseline to 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2013
- Study completionNov 2013
Why it stopped: Terminated due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cutaneous T-cell Lymphoma Stage IStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Andrei Shustov, University of Washington
- Investigators
- Andrei Shustov, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958074
- Sponsor's protocol ID
- 6914
- Other IDs
- NCI-2009-01231
- Status last verified
- Sep 2018
- First submitted
- 10 Aug 2009
- Last updated
- 18 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective Non-Randomized Clinical Trial of Dose-Adjusted Schedule of Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma Who Did Not Receive Prior Systemic Therapy or Have Been Treated With Single Agent Targretin
- ClinicalTrials.gov ID
- NCT00958074
- Acronym / sponsor ID
- 6914
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 15 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- To determine the objective response rate to treatment with dose-adjusted Vorinostat schedule in subjects with cutaneous T-cell lymphoma (CTCL) who did not receive prior systematic therapy or have been treated with single agent targretin (bexarotene).
SECONDARY OBJECTIVES:
- To determine the safety and tolerability of dose-adjusted Vorinostat schedule when administered to patients with primary cutaneous T-cell lymphoma who did not receive prior systematic therapy or have been treated with single agent targretin.
II. To determine the time to objective response in subjects with CTCL treated with dose-adjusted schedule of Vorinostat as primary therapy.
III To determine the duration of objective response in subjects with CTCL.
IV. To determine the time to loss of objective response.
- To determine the objective response rate of extracutaneous manifestations of CTCL (lymph node enlargement, Sezary cells in peripheral blood).
VI. To compare the efficacy, toxicity and tolerability of dose-adjusted schedule to currently recommended flat dose of Vorinostat in subjects with CTCL.
OUTLINE: Patients are assigned to 1 of 2 treatment arms according to age (< 65 vs >= 65 years old).
COHORT I (>= 65 years old): Patients receive 200 mg vorinostat orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
COHORT II (< 65 years old): Patients receive 400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (>=65 years old) | Experimental | Drug: vorinostat, Other: flow cytometry, Other: laboratory biomarker analysis200 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. |
| Cohort II (<65 years old) | Experimental | Drug: vorinostat, Other: flow cytometry, Other: laboratory biomarker analysis400 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vorinostatAlso: L-001079038, SAHA, suberoylanilide hydroxamic acid, ZolinzaGiven PO | Drug | Cohort I (>=65 years old), Cohort II (<65 years old) |
| flow cytometrycorrelative study | Other | Cohort I (>=65 years old), Cohort II (<65 years old) |
| laboratory biomarker analysiscorrelative study | Other | Cohort I (>=65 years old), Cohort II (<65 years old) |
Primary outcome
Objective Response
Time frame: After at least 14 days. With Confirmation after additional 28 days.
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.
4 secondary outcomes
Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood);
Time frame: Up to 30 days post-treatment
Occurrences of Dose Adjustment as Measured by Safety/Toxicity
Time frame: Up to 30 days post-treatment
Number of Participants With Overall Response as Measured by Sezary Cell Count
Time frame: Baseline to 30 days post-treatment
Changes in the Physicians Serial Assessment of Erythroderma Score
Time frame: Baseline to 30 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Shustov principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vorinostat, flow cytometry and laboratory biomarker analysis in people with Cutaneous T-cell Lymphoma Stage I and Cutaneous T-cell Lymphoma Stage II, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response (time frame: After at least 14 days. With Confirmation after additional 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.