Trial record 1 of 1 for:    ADI-PEG 20, small cell
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Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Memorial Sloan-Kettering Cancer Center
Duke University
St. Bartolomew's Hospital
St. Luc Hospital
Krakenhaus Nordwest
National Taiwan University Hospital
Chang Gung Memorial Hospital - LinKou Branch
National ChengKung University Hospital
Polaris Group
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT01266018
First received: December 22, 2010
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: ADI-PEG 20 (Arginine deiminase pegylated)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • Assessment of clinical efficacy of tumor response by RECIST after 4 weeks [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of safety of ADI-PEG 20 [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of pharmacodynamics of ADI-PEG 20 [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Assessment of immunogenicity of ADI-PEG 20 [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Assessment of overall survival [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: December 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Sensitive Disease
Cohort 1 consists of "sensitive" disease patients, who had one previous line of chemotherapy and maintained an appropriate response for 90 days or more.
Drug: ADI-PEG 20 (Arginine deiminase pegylated)
ADI-PEG 20 will be administered intramuscularly (IM) at a fixed dose of 320 IU/m2 once weekly for a 4-week cycle
Other Names:
  • ADI
  • Arginine deiminase pegylated
Experimental: Cohort 2: Refractory Disease
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.
Drug: ADI-PEG 20 (Arginine deiminase pegylated)
ADI-PEG 20 will be administered intramuscularly (IM) at a fixed dose of 320 IU/m2 once weekly for a 4-week cycle
Other Names:
  • ADI
  • Arginine deiminase pegylated

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266018

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Belgium
University Clinic Saint-Luc
Brussels, Belgium, B-1200
Germany
Krankenhaus Nordwest
Frankfurt, Germany, D-60488
Taiwan
National Cheng Kung University Hospital
Tainan City, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 10002
Chang Gung Memorial Hospital - LinKou Branch
Taoyuan, Taiwan, 333
United Kingdom
St. Bartholomew's Hospital
West Smithfield, London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Memorial Sloan-Kettering Cancer Center
Duke University
St. Bartolomew's Hospital
St. Luc Hospital
Krakenhaus Nordwest
National Taiwan University Hospital
Chang Gung Memorial Hospital - LinKou Branch
National ChengKung University Hospital
Polaris Group
  More Information

No publications provided

Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT01266018     History of Changes
Other Study ID Numbers: LUD2009-007, Pro00022622
Study First Received: December 22, 2010
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
small cell lung cancer
SCLC
ADI-PEG 20
arginine deiminase pegylated

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014