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Chronic Lymphocytic LeukemiaPhase 2PR-CS008NCT00514696

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

A Phase 2 study testing GCS-100 in people with Chronic Lymphocytic Leukemia, run by La Jolla Pharmaceutical Company at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
GCS-100
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
8 sitesUnited States
Study dates
Feb 2007to Apr 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Dayton Oncology & Hematology

    Kettering, Ohio, 45409

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists - Vancouver Cancer Center

    Vancouver, Washington, 98684

  • Cancer Centers of Florida

    Winter Park, Florida, 32789

  • Yakima Cancer Center

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
GCS-100
Keywords
Cancer, Leukemia, GCS-100, CLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GCS-100Drug

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

Study groups in NCT00514696
Study groupRoleWhat they receive
GCS-100ExperimentalGCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle
Receives: Drug: GCS-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 15 cycles X 21 days

Secondary outcomes (1)

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00514696
Sponsor's protocol ID
PR-CS008
Acronym
PR-CS008
Status last verified
Jun 2013
First submitted
8 Aug 2007
Last updated
17 Jun 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GCS-100 in people with Chronic Lymphocytic Leukemia, run by La Jolla Pharmaceutical Company at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00514696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.

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