Overview

This trial is active, not recruiting.

Condition small cell lung cancer
Treatment adi-peg 20 (arginine deiminase pegylated)
Phase phase 2
Sponsor Ludwig Institute for Cancer Research
Collaborator Memorial Sloan-Kettering Cancer Center
Start date December 2010
End date August 2013
Trial size 45 participants
Trial identifier NCT01266018, LUD2009-007, Pro00022622

Summary

This is an open-label, phase II study of ADI-PEG 20 in subjects with relapsed SCLC. ADI-PEG 20 will be administered intramuscularly (IM) at a fixed dose of 320 IU/m2 once weekly for a 4-week cycle. The primary objective is the assessment of clinical efficacy with a primary endpoint of tumor response by RECIST after 4 weeks. Secondary objectives are the assessment of safety, pharmacodynamics, and immunogenicity of ADI-PEG 20, as well as, clinical efficacy with a secondary endpoint of overall survival.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cohort 1 consists of "sensitive" disease patients, who had one previous line of chemotherapy and maintained an appropriate response for 90 days or more.
adi-peg 20 (arginine deiminase pegylated) ADI
ADI-PEG 20 will be administered intramuscularly (IM) at a fixed dose of 320 IU/m2 once weekly for a 4-week cycle
(Experimental)
Cohort 2 consists of (a) "refractory" disease patients, who had one previous line of chemotherapy and either had no response or progressed in less than 90 days after completing treatment or (b) any patient (sensitive or refractory) in need of 3rd line therapy, i.e., who completed or failed two previous lines of chemotherapy.
adi-peg 20 (arginine deiminase pegylated) ADI
ADI-PEG 20 will be administered intramuscularly (IM) at a fixed dose of 320 IU/m2 once weekly for a 4-week cycle

Primary Outcomes

Measure
Assessment of clinical efficacy of tumor response by RECIST after 4 weeks
time frame: Every 4 weeks

Secondary Outcomes

Measure
Assessment of safety of ADI-PEG 20
time frame: Every 4 weeks
Assessment of pharmacodynamics of ADI-PEG 20
time frame: Every 4 weeks
Assessment of immunogenicity of ADI-PEG 20
time frame: Every 4 weeks
Assessment of overall survival
time frame: Every 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients must have histologically documented small cell lung cancer (SCLC) 2. Cohort 1: "Sensitive" disease patients who had one previous line of chemotherapy and maintained an appropriate response for 90 days or more Cohort 2: - "refractory" disease patients, who had one previous line of chemotherapy and either had no response or progressed in less than 90 days after completing treatment - any patient ("sensitive" or "refractory") in need of 3rd line therapy, i.e., who completed or failed two previous lines of chemotherapy 3. Measurable disease using RECIST criteria 4. ASS tumor expression must be either negative or < 5% + tumor cells (by IHC analysis) 5. ECOG performance score of 0 to 2 6. Laboratory parameters for vital functions should be in the normal range. Laboratory abnormalities that are not clinically significant are generally permitted, except for the following laboratory parameters, which must be within the ranges specified: - Neutrophil count ≥ 1.5 x 109/L - Lymphocyte count ≥ 0.5 x 109/L - Platelet count ≥ 50 x 109/L - Serum creatinine ≤ 1.5 ULN (or CrCl ≥ 60mL/min) - Serum bilirubin ≤ 2mg/dL (or ≤ 34 µmol/L) - Serum uric acid ≤ 8mg/dL (or ≤ 0.48 mmol/L) - INR ≤ 1.5 - Partial thromboplastin time ≤ 1.5 x ULN 7. Age ≥ 18 years 8. Able and willing to give valid written informed consent Exclusion Criteria: 1. Subjects previously treated with ADI-PEG 20 2. Known allergy to pegylated products. 3. History of uncontrolled seizure. 4. Serious illnesses, e.g. serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would interfere with the ability of the patient to fulfill the study requirements. 5. Metastatic disease to the central nervous system, unless treated and stable. 6. Known immunodeficiency or HIV positivity. 7. Participation in any other clinical trial involving another investigational agent within 3 weeks prior to first dosing of study agent. 8. Any other malignancy that requires concomitant therapy restricted according to Section 5.3. 9. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 10. Lack of availability for clinical follow-up assessment. 11. Pregnancy or breast feeding. 12. Refusal or inability to use effective means of contraception for men and women of childbearing potential for the duration of the study.

Additional Information

Official title Phase II Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Ludwig Institute for Cancer Research.