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

NCT00514696 | Completed Phase 2 DMC

• 1 other identifier: PR-CS008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Cancer; Leukemia; GCS-100; CLL

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 15 cycles X 21 days

Secondary Outcomes (1)

• 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

  Hour 6 after Day 1 dosing, and Days 4 and 8

Study Arms (1)

GCS-100

EXPERIMENTAL

GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle

Drug: GCS-100

Interventions

GCS-100 DRUG

GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle

GCS-100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: lead

Study Sites (8)

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Cancer Centers of Florida

Winter Park, Florida, 32789, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

Dayton Oncology & Hematology

Kettering, Ohio, 45409, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Northwest Cancer Specialists - Vancouver Cancer Center

Vancouver, Washington, 98684, United States

Location

Yakima Cancer Center

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms; Leukemia

Interventions

GCS-100

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Smith, MD

  US Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 10, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

US (8)