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Study of the Safety of GCS-100 in Subjects With Chronic Lymphocytic Leukemia (PR-CS008)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00514696
First received: August 8, 2007
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: GCS-100
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Phase 2 Study of the Safety and Biological Activity of GCS-100 in Subjects With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by La Jolla Pharmaceutical Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: February 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GCS-100
GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle
Drug: GCS-100
GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle

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.

  Eligibility

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

Inclusion Criteria:

Eligible subjects must meet all of the following criteria:

  1. Subject is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent.
  2. Subject is male or female, aged at least 18 years.
  3. Subject has been diagnosed with chronic lymphocytic leukemia.
  4. 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.
  5. Subject has received 2 or fewer prior therapies for his/her chronic lymphocytic leukemia.
  6. Subject does not currently require blood transfusions.
  7. Subject's peripheral blood leukocyte count is > 10,000 cells/mm3.
  8. Subject's Karnofsky performance status is > 60%.
  9. Subject's life expectancy is at least 3 months.
  10. 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.
  11. 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:

  1. Subject received biologic therapy and/or chemotherapy that may be active against chronic lymphocytic leukemia within the 4 weeks prior to Study Day 1.
  2. Subject is anticipated to require steroid therapy within the next 21 days.
  3. Subject received an investigational (i.e., experimental) therapy within the 4 weeks prior to Study Day 1.
  4. 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
  5. Subject has a known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C infection.
  6. 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.
  7. Subject had major surgery within the 4 weeks prior to Study Day 1.
  8. 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.
  9. If female, subject is pregnant or breast-feeding.
  10. 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.
  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: NCT00514696

Locations
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Florida
Cancer Centers of Florida
Winter Park, Florida, United States, 32789
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Ohio
Dayton Oncology & Hematology
Kettering, Ohio, United States, 45409
United States, Texas
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, United States, 98684
Yakima Cancer Center
Yakima, Washington, United States, 98902
Sponsors and Collaborators
La Jolla Pharmaceutical Company
Investigators
Principal Investigator: David Smith, MD US Oncology
  More Information

No publications provided

Responsible Party: La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT00514696     History of Changes
Other Study ID Numbers: PR-CS008
Study First Received: August 8, 2007
Last Updated: June 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by La Jolla Pharmaceutical Company:
Cancer
Leukemia
GCS-100
CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014