Trial Outcomes & Findings for Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL (NCT NCT00724061)

Last Updated: 2018-12-12

Results Overview

Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity.

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)

Results posted on

2018-12-12

Participant Flow

Study opened at Northwestern University in 09/2008 with an accrual goal of 15 subjects. The study was suspended from 11/2009 to 07/2010 due to a shortage of psoralens; a revision allowed the use of PUVA or NB-UVB for UV therapy. A total of 7 patients were enrolled before the study was closed due to poor accrual in 05/2012.

Participant milestones

Participant milestones
Measure	PEG-IFN-alpha-2b + UV Therapy Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
Dose Escalation Phase STARTED	7
Dose Escalation Phase COMPLETED	2
Dose Escalation Phase NOT COMPLETED	5
Maintenance Therapy STARTED	2
Maintenance Therapy COMPLETED	2
Maintenance Therapy NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PEG-IFN-alpha-2b + UV Therapy Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
Dose Escalation Phase Adverse Event	2
Dose Escalation Phase Disease Progression	3

Baseline Characteristics

Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEG-IFN-alpha-2b + UV Therapy n=7 Participants Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
Sex: Female, Male Female	3 Participants n=5 Participants
Age, Customized 30-39	1 participants n=5 Participants
Age, Customized 40-49	2 participants n=5 Participants
Age, Customized 50-59	2 participants n=5 Participants
Age, Customized 60-69	0 participants n=5 Participants
Age, Customized 70-79	2 participants n=5 Participants
Age, Customized 80-89	0 participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)

Outcome measures

Outcome measures
Measure	PEG-IFN-alpha-2b + UV Therapy n=7 Participants Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b	0 dose limiting toxicities

PRIMARY outcome

Timeframe: During 12 weeks of dose escalation and then up to one year during maintenance therapy.

Population: No data collected for this outcome measure.

The FACT-BRM is a patient self-report tool to assess health-related quality of life measures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During 12 weeks of dose escalation and then up to one year during maintenance therapy.

Population: No data collected for this outcome measure.

Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease. CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (\< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At each study visit

Population: No data collected for this outcome measure.

To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and after 2 weeks of treatment (for those patients who consented to this portion)

The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase

Outcome measures

Outcome data not reported

Adverse Events

PEG-IFN-alpha-2b + UV Therapy

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PEG-IFN-alpha-2b + UV Therapy n=7 participants at risk Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Cardiac disorders Ventricular arrhythmia - ventricular tachycardia	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.

Other adverse events

Other adverse events
Measure	PEG-IFN-alpha-2b + UV Therapy n=7 participants at risk Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
Metabolism and nutrition disorders ALT, SGPT elevation	57.1% 4/7 • Number of events 5 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Metabolism and nutrition disorders AST, SGOT elevation	71.4% 5/7 • Number of events 6 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	42.9% 3/7 • Number of events 7 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Gastrointestinal disorders Anorexia	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Skin and subcutaneous tissue disorders Burn	14.3% 1/7 • Number of events 2 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
General disorders Constitutional symptoms - other (fever, chills, sweats, aches & pains)	28.6% 2/7 • Number of events 3 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Metabolism and nutrition disorders Creatinine - elevation	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Gastrointestinal disorders Diarrhea	28.6% 2/7 • Number of events 2 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
General disorders Fatigue	85.7% 6/7 • Number of events 7 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
General disorders Fever	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	71.4% 5/7 • Number of events 7 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Blood and lymphatic system disorders Hemoglobin (decrease)	57.1% 4/7 • Number of events 5 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Skin and subcutaneous tissue disorders Hypopigmentation - slight or localized	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Skin and subcutaneous tissue disorders Infection - skin (cellulitis)	14.3% 1/7 • Number of events 2 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
General disorders Insomnia	14.3% 1/7 • Number of events 2 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Blood and lymphatic system disorders Leukocytes (total WBC) - decreased	71.4% 5/7 • Number of events 8 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Blood and lymphatic system disorders Lymphopenia	71.4% 5/7 • Number of events 6 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue - other (injection site pain)	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC) - decreased	42.9% 3/7 • Number of events 7 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
General disorders Odor (patient)	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Blood and lymphatic system disorders Other impact on blood/bone marrow	28.6% 2/7 • Number of events 2 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
General disorders Pain - head/headache	42.9% 3/7 • Number of events 4 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Musculoskeletal and connective tissue disorders Pain - muskuloskeletal	28.6% 2/7 • Number of events 3 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Blood and lymphatic system disorders Platelets (decreased)	42.9% 3/7 • Number of events 6 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Skin and subcutaneous tissue disorders Pruritus/itching - mild or localized	57.1% 4/7 • Number of events 4 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
Skin and subcutaneous tissue disorders Rash/desquamation	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
General disorders Rigors/chills	14.3% 1/7 • Number of events 1 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
General disorders Weight loss - intervention not indicated	42.9% 3/7 • Number of events 3 • Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.

Additional Information

Dr. Timothy Kuzel

Northwestern University

Phone: 312-695-6180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place