Study of the Safety of GCS-100 in Subjects With Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID: NCT00514696
Run by: La Jolla Pharmaceutical Company
People needed: 12
Starts: 2007-02-01
Expected to finish: 2009-04-01
Last updated by the study team: 2013-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Rocky Mountain Cancer Centers — Denver, Colorado, United States
Cancer Centers of Florida — Winter Park, Florida, United States
Central Indiana Cancer Centers — Indianapolis, Indiana, United States
Dayton Oncology & Hematology — Kettering, Ohio, United States
Tyler Cancer Center — Tyler, Texas, United States
Virginia Oncology Associates — Norfolk, Virginia, United States
Northwest Cancer Specialists - Vancouver Cancer Center — Vancouver, Washington, United States
Yakima Cancer Center — Yakima, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.