- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00514696
Study of the Safety of GCS-100 in Subjects With Chronic Lymphocytic Leukemia (PR-CS008)
June 14, 2013 updated by: La Jolla Pharmaceutical Company
Open Label Phase 2 Study of the Safety and Biological Activity of GCS-100 in Subjects With Chronic Lymphocytic Leukemia
The purpose of this study is to evaluate the safety of GCS-100 and the biologic activity of GCS-100 in subjects with chronic lymphocytic leukemia.
Study Overview
Detailed Description
The primary objective of this study is to evaluate the safety of GCS-100, and effect of GCS-100 on markers of apoptosis in subjects with chronic lymphocytic leukemia.
The secondary objective of this study is to evaluate the effect of GCS-100 on peripheral blood leukocyte count in subjects with chronic lymphocytic leukemia.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers
-
-
Florida
-
Winter Park, Florida, United States, 32789
- Cancer Centers of Florida
-
-
Indiana
-
Indianapolis, Indiana, United States, 46219
- Central Indiana Cancer Centers
-
-
Ohio
-
Kettering, Ohio, United States, 45409
- Dayton Oncology & Hematology
-
-
Texas
-
Tyler, Texas, United States, 75702
- Tyler Cancer Center
-
-
Virginia
-
Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
-
-
Washington
-
Vancouver, Washington, United States, 98684
- Northwest Cancer Specialists - Vancouver Cancer Center
-
Yakima, Washington, United States, 98902
- Yakima Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Eligible subjects must meet all of the following criteria:
- Subject is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent.
- Subject is male or female, aged at least 18 years.
- Subject has been diagnosed with chronic lymphocytic leukemia.
- Subject has Stage II or higher, chronic lymphocytic leukemia that currently requires therapy due to the severity of the disease symptoms and/or to the presence of increasing anemia and/or increasing splenomegaly.
- Subject has received 2 or fewer prior therapies for his/her chronic lymphocytic leukemia.
- Subject does not currently require blood transfusions.
- Subject's peripheral blood leukocyte count is > 10,000 cells/mm3.
- Subject's Karnofsky performance status is > 60%.
- Subject's life expectancy is at least 3 months.
- Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least 1 year), and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception throughout the entire study period.
- Subject is willing and able to comply with the prescribed treatment protocol and evaluations.
Exclusion Criteria:
Subjects will be ineligible for study participation if they meet any of the following criteria:
- Subject received biologic therapy and/or chemotherapy that may be active against chronic lymphocytic leukemia within the 4 weeks prior to Study Day 1.
- Subject is anticipated to require steroid therapy within the next 21 days.
- Subject received an investigational (i.e., experimental) therapy within the 4 weeks prior to Study Day 1.
Subject's clinical laboratory values meet any of the following criteria within the 7 days prior to Study Day 1:
- Platelet count < 25,000 cells/mm3
- Absolute neutrophil count < 500 cells/mm3
- Hemoglobin < 8.0 g/dL and with an autoimmune hemolytic component to the subject's anemia
- AST and/or ALT > 2.5 X the upper limit of normal
- Total bilirubin > 1.5 X the upper limit of normal
- Serum creatinine > 2 mg/dL
- Subject has a known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C infection.
- Subject has a clinically relevant active infection and/or a serious co-morbid medical condition, such as recent myocardial infarction, unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, cirrhosis, inflammatory bowel disease.
- Subject had major surgery within the 4 weeks prior to Study Day 1.
- Subject had another malignancy within the 3 years prior to study entry, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or other cancer for which the subject has been disease-free for at least 3 years.
- If female, subject is pregnant or breast-feeding.
- Subject has a concomitant disease or condition, including laboratory abnormalities, which in the opinion of the Investigator could interfere with the conduct of the study or could put the subject at unacceptable risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GCS-100
GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle
|
GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To Evaluate the effect of GCS-100 on markers of apoptosis in subjects with chronic lymphocytic leukemia using physical examinations, vital signs, lab assessments, and adverse event reporting
Time Frame: Up to 15 cycles X 21 days
|
Up to 15 cycles X 21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the effect of GCS-100 on peripheral blood leukocyte count in subjects with chronic lymphocytic leukemia using complete blood count, leukocyte count and circulating cells for apoptosis
Time Frame: Hour 6 after Day 1 dosing, and Days 4 and 8
|
Hour 6 after Day 1 dosing, and Days 4 and 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Smith, MD, US Oncology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
August 8, 2007
First Submitted That Met QC Criteria
August 9, 2007
First Posted (Estimate)
August 10, 2007
Study Record Updates
Last Update Posted (Estimate)
June 17, 2013
Last Update Submitted That Met QC Criteria
June 14, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-CS008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Lymphocytic Leukemia
-
National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingLeukemia, Lymphocytic, Chronic, B-Cell | Chronic Lymphocytic Leukemia | Leukemia, Chronic Lymphatic | B-Cell Chronic Lymphocytic Leukemia | Leukemia, Lymphocytic, Chronic | B-Lymphocytic Leukemia, Chronic | Leukemia, Chronic Lymphocytic, B-Cell | Lymphocytic Leukemia, Chronic, B Cell | Lymphocytic Leukemia...United States
-
National Cancer Institute (NCI)TerminatedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)TerminatedLeukemia | B-cell Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Celgene CorporationTerminatedChronic Lymphocytic Leukemia | B-cell Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
-
Roswell Park Cancer InstituteWithdrawnRefractory Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic Leukemia
-
National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic LeukemiaUnited States
Clinical Trials on GCS-100
-
La Jolla Pharmaceutical CompanyCompleted
-
La Jolla Pharmaceutical CompanyCompleted
-
La Jolla Pharmaceutical CompanyWithdrawn
-
La Jolla Pharmaceutical CompanyUnknownDiabetic Chronic Kidney DiseaseUnited States
-
La Jolla Pharmaceutical CompanyCompletedChronic Kidney DiseaseUnited States
-
Uludag UniversityRecruitingBrain Injuries, TraumaticTurkey
-
University Hospital Inselspital, BerneRoche Pharma AG; University of BernCompleted
-
Pirogov Russian National Research Medical UniversityMedtronicCompletedVenous Thrombosis | Venous ThromboembolismRussian Federation
-
Fujian Medical University Union HospitalEnrolling by invitationLupus Erythematosus, Systemic | Purpura, Thrombocytopenic, Idiopathic | Glucocorticoids | Adverse Effect of GlucocorticoidsChina
-
Capital Medical UniversityCompletedIntensive Care UnitChina