Non-Hodgkin's Lymphoma
Conditions
Keywords
Argininosuccinate Synthetase, Arginine, Arginine deiminase, Failed prior systemic therapy
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.
Interventions
DRUGADI-PEG 20
Sponsors
Polaris Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
A subject will not be eligible for study participation if he/she meets any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 2 years estimated | Determined by response criteria for cutaneous and non-cutaneous malignant lymphoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 2 years estimated | Progression free survival - time from start of therapy until proven progression or death Overall survival Time on treatment Disease control rate Determine the pharmacodynamics of ADI-PEG 20 Determine the immunogenicity of ADI-PEG 20 |
Countries
Taiwan
Outcome results
None listed