Status:
TERMINATED
Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Duke University
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a 2-arm, open-label, phase 2 study of pegylated arginine deiminase (ADI-PEG) 20 in subjects with relapsed sensitive or refractory small cell lung cancer (SCLC). ADI-PEG 20 was administered in...
Detailed Description
Subjects were enrolled sequentially (non-randomized) into two separate cohorts in parallel. Cohort 1 comprised subjects with "sensitive" disease and Cohort 2 comprised subjects with "refractory" disea...
Eligibility Criteria
Inclusion
- Subjects must have had histologically documented SCLC
- Assigned to one of two cohorts based on the following characteristics: Cohort 1: "Sensitive" disease subjects who had 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more; or Cohort 2: "Refractory" disease subjects, who had (a) 1 previous line of chemotherapy and either had no response or progressed in less than 90 days after completing treatment or (b) any subject ("sensitive" or "refractory") in need of third-line therapy, i.e., who completed or failed 2 previous lines of chemotherapy
- Measurable disease using RECIST version 1.1
- Argininosuccinate synthetase (ASS) tumor expression was either negative or \< 5% + tumor cells by immunohistochemistry analysis
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
- Laboratory parameters for vital functions in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which were to be within the ranges specified:
- Neutrophil count: ≥ 1.5 x 10\^9/L
- Lymphocyte count: ≥ 0.5 x 10\^9/L
- Platelet count: ≥ 50 x 10\^9/L
- Serum creatinine: ≤ 1.5 x upper limit of normal (ULN) (or creatinine clearance ≥ 60 mL/min)
- Serum bilirubin: ≤ 2 mg/dL (or ≤ 34 µmol/L)
- Serum uric acid: ≤ 8 mg/dL (or ≤ 0.48 mmol/L)
- International normalized ratio (INR): ≤ 1.5
- Partial thromboplastin time: ≤ 1.5 x ULN
- Age ≥ 18 years
- Able and willing to give valid written informed consent
Exclusion
- Previous treatment with ADI-PEG 20
- Known allergy to pegylated products
- History of uncontrolled seizures
- 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
- Metastatic disease to the central nervous system, unless treated and stable
- Known immunodeficiency or human immunodeficiency virus (HIV) positivity
- Participation in another clinical trial involving another investigational agent within 3 weeks prior to first dosing of study agent
- Any other malignancy that required protocol-specified restricted concomitant therapy
- Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study
- Lack of availability for clinical follow-up assessment
- Pregnancy or breast feeding
- Refusal or inability to use effective means of contraception for men and women of childbearing potential for the duration of the study
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01266018
Start Date
January 1 2011
End Date
January 1 2014
Last Update
October 25 2022
Active Locations (8)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
University Clinic Saint-Luc
Brussels, Belgium, B-1200
4
Krankenhaus Nordwest
Frankfurt, Germany, D-60488