PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy

NCT ID: NCT01910025

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-06
• Study Completion Date: 2017-12-15

Brief Summary

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that have arginine. In this study, the primary efficacy variable will be assessment of tumor response rate.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADI-PEG 20

arginine deiminase formulated with polyethlene glycol

Group Type: EXPERIMENTAL

ADI-PEG 20

Intervention Type: DRUG

Interventions

ADI-PEG 20

Intervention Type: DRUG

Other Intervention Names

arginine deiminase formulated with polyethylene glycol

Eligibility Criteria

Inclusion Criteria

1. Histologically proved NHL (B and T cells) according to WHO criteria and have relapsed or are refractory to at least 2 prior systemic chemotherapies (excluding chronic lymphocytic leukemia and Waldenstrom's macroglobulinemia).

2. Measurable disease as assessed by IHP criteria (Appendices A and B).

3. Age ≥ 20 years.

4. ECOG performance status of 0-2.

5. No prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 2 weeks prior to first dose of study treatment.

6. Fully recovered from any prior surgery and no major surgery within 4 weeks of initiating treatment. Surgery for placement of vascular access devices is acceptable.

7. Post-menarche female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. Females must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study.

8. Informed consent must be obtained prior to study initiation.

9. No concurrent investigational studies are allowed.

10. Absolute neutrophil count (ANC) >750/µL.

11. Platelets >50,000/µL.

12. Serum uric acid ≤ 8 mg/dL (with or without medication control).

13. Creatinine clearance must be ≥ 30 mL/min. This can be calculated using the Cockcroft-Gault equation: estimated creatinine clearance = [(140 - age) x weight (in kg)] / serum creatinine (in mg/dl) x 72; for females, multiple result by 0.85.

Exclusion Criteria

1. Patients with infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study; patients on prophylactic antibiotics or antivirals are acceptable.

2. Pregnancy or lactation.

3. Expected non-compliance.

4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.

5. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both.

6. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current ASS negative cancer diagnosis.

7. Subjects who had been treated with ADI-PEG 20 previously.

8. History of seizure disorder not related to underlying cancer.

9. Known HIV positivity (testing not required).

10. Autologous or allogenic stem cell transplantation within 3 months before the first dose of study treatment.

11. Systemic steroids that have not been stabilized to the equivalent of ≧ 15 mg/day of prednisone 7 days prior to first dose of study treatment.

12. CNS lymphoma.

13. Allergy to pegylated compounds.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polaris Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Medical Foundation-Kaohsiung

Kaohsiung City, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

CMUH

Taichung, , Taiwan

National Cheng Kung University Hospital(NCKUH)

Tainan City, , Taiwan

CGMH-LK

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

POLARIS2012-002

Identifier Type: -

Identifier Source: org_study_id