Trial Outcomes & Findings for Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma (NCT NCT00958074)

Last Updated: 2018-10-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

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

Results posted on

2018-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort I (>=65 Years Old) 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study
Overall Study STARTED	4	7
Overall Study COMPLETED	4	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort I (>=65 Years Old) 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort I (>=65 Years Old) n=4 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) n=7 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

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

Population: In cohort 1, only 3 of the 4 subjects consented were used for analysis. 1 patient in this cohort only completed 3 days of treatment before removing themselves from treatment and withdrawing consent. This patient was deemed inevaluable, as the timeframe for initial evaluation is 14 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.

Outcome measures

Outcome measures
Measure	Cohort I (>=65 Years Old) n=3 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) n=7 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study
Objective Response	0 percentage of total	57 percentage of total

SECONDARY outcome

Timeframe: Up to 30 days post-treatment

Population: 7 subjects with nodal disease (2 subjects \>=65 and 5 subjects \<= 65: 1 not evaluable)

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.

Outcome measures

Outcome measures
Measure	Cohort I (>=65 Years Old) n=2 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) n=4 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study
Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood); Stable Disease	2 participants	3 participants
Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood); Progressive Disease	0 participants	1 participants
Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood); Overall Response	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 30 days post-treatment

Population: 4 subjects \>= 65, 7 subjects \<= 65 who received at least one dose of drug.

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.

Outcome measures

Outcome measures
Measure	Cohort I (>=65 Years Old) n=4 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) n=7 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study
Occurrences of Dose Adjustment as Measured by Safety/Toxicity Dose delay	1 Occurrences	2 Occurrences
Occurrences of Dose Adjustment as Measured by Safety/Toxicity Dose reduction	1 Occurrences	1 Occurrences
Occurrences of Dose Adjustment as Measured by Safety/Toxicity Treatment discontinuation	1 Occurrences	0 Occurrences

SECONDARY outcome

Timeframe: Baseline to 30 days post-treatment

Overall response defined by a clinically significant decrease in Sezary cell count (\>50% decrease from baseline).

Outcome measures

Outcome measures
Measure	Cohort I (>=65 Years Old) n=2 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) n=4 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study
Number of Participants With Overall Response as Measured by Sezary Cell Count Overall response	2 participants	1 participants
Number of Participants With Overall Response as Measured by Sezary Cell Count Stable disease	0 participants	3 participants

SECONDARY outcome

Timeframe: Baseline to 30 days post-treatment

Population: 2 subjects \>= 65, 3 subjects \<= 65 with baseline erythroderma score.

Outcome measures

Outcome measures
Measure	Cohort I (>=65 Years Old) n=2 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) n=3 Participants 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study
Changes in the Physicians Serial Assessment of Erythroderma Score No change	2 Participants	0 Participants
Changes in the Physicians Serial Assessment of Erythroderma Score Reduction	0 Participants	3 Participants
Changes in the Physicians Serial Assessment of Erythroderma Score Resolution	0 Participants	2 Participants

Adverse Events

Cohort I (>=65 Years Old)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort II (<65 Years Old)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort I (>=65 Years Old) n=4 participants at risk 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study	Cohort II (<65 Years Old) n=7 participants at risk 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. vorinostat: Given PO flow cytometry: correlative study laboratory biomarker analysis: correlative study
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/4 • Adverse Events were collected from the time of signing consent until 30 days after the last dose of study drug treatment administered or until any treatment related AE or laboratory abnormality resolved or stabilized.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from the time of signing consent until 30 days after the last dose of study drug treatment administered or until any treatment related AE or laboratory abnormality resolved or stabilized.

Other adverse events

Additional Information

Dr. Andrei Shustov

University of Washington

Phone: 206-288-6744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60