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View Clinical Trial (Medical Research Study)
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A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease - NCT00412321- (Clinical Trial 157318)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy157318.aspx
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Seattle |
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State:
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WA |
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| Conditions: |
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Giant Lymph Node Hyperplasia - Lymphoma, Non-Hodgkin - Multiple Myeloma |
| Purpose: |
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The purpose of this study is to evaluate of the study of different CNTO 328 doses and
schedules and to see if CNTO 328 has any effect on Non-hodgkin's Lymphoma, Multiple Myeloma
or Castleman's disease.
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| Study summary: |
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This research study will use a type of drug called anti-IL-6 antibody, also known as CNTO
328. An antibody is a substance in the body that fights infection. CNTO 328 is an
investigational drug that has been shown to slow down tumor growth or shrink tumors when
tested in animals. In a previous clinical trial in patients with multiple myeloma (blood
cancer), CNTO 328 appeared to be a potent inhibitor of IL-6 . One study has been completed
for kidney cancer. There are studies ongoing in humans with multiple myeloma and prostate
cancer to see if CNTO 328 is safe and to see what effects it has on these types of cancer.
This is an open-label, nonrandomized, dose-finding phase 1 study with CNTO 328 in patients
with B- cell non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's disease. The purpose
of this study is to evaluate different doses and schedules of CNTO 328 to see which
dose/schedule is safe. CNTO 328 will be given through a small tube that goes directly into
your vein, called an intravenous (IV) infusion. Depending on when the patient enters the
study, the patient will be assigned to receive one course of CNTO 328 in one of the
following groups: Group 1: 3 mg/kg 2 hr IV infusion every 2 weeks for 4 doses. Group 2: 6
mg/kg 2 hr IV infusion every 2 weeks for 4 doses. Group 3: 12 mg/kg 2 hr IV infusion every
3 weeks for 3 doses. Group 4: 6 mg/kg 2 hr IV infusion every week for 7 doses. Group 5: 12
mg/kg 2 hr IV infusion every 2 weeks for 4 doses. Group 6: 12 mg/kg 1 hr IV infusion every
3 weeks for 3 doses. Group 7: 9 mg/kg 1 hr IV infusion every 3 weeks for Castleman's
patients only. In Groups 1-5, the overall amount of study drug that will be given increases
with each higher group. Group 1 will be filled before Group 2 starts and Group 2 will be
filled before Group 3 starts, etc. In this way, CNTO 328 can be tested more safely. Both the
patient and the study doctor will know to which group the patient is assigned. Patients will
remain in the group that they are assigned to for the entire time of participation in the
study. Up to 70 patients may take part in this study. Patients in Groups 1-6 will be in the
study for up to 34 weeks prior to Post Study Follow-Up. Screening: up to 4 weeks before the
first dose schedule of CNTO 328. Treatment: up to 6 weeks of treatment with CNTO 328.
Extended Dosing: Patients assigned to Groups 1-6, and their cancer or disease has become
stable or better while receiving CNTO 328, may be able to receive additional courses of
study drug. Patients in Group 7 will be in the study until their disease gets worse, they
can no longer tolerate CNTO 328, the study doctor feels it is in their best interest to stop
CNTO 328 or they longer wish to participate in the study. Long Term Follow-Up: Patients
will be contacted by telephone every six months after the last infusion of study drug to
assess the patient's disease status and survival. If the patient's cancer or disease has
become stable or better while receiving CNTO 328, patients may be able to receive additional
courses of study drug. Dose (6-12 mg/kg) and frequency (weekly or 2 or 3 week intervals) of
dosing depends upon Group assignment. CNTO 328 will be given through a small tube that goes
directly into your vein, called an intravenous (IV) infusion. The infusion will take about 2
hours to complete for groups 1-5 and 1 hour for Groups 6 and 7. In Groups 1-6, CNTO 328 will
be given once every 1, 2 or 3 weeks from days 1 to 43 depending on treatment assignment.
Group 7, CNTO 328 will be given on day 1 of each 21 day cycle. |
| Criteria: |
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Inclusion Criteria:
- Diagnosed with B-cell non-Hodgkin's lymphoma, multiple myeloma, or Castleman's
Disease which has progressed on or after standard therapy or for which there is no
effective standard therapy, or which is not suitable for standard therapy
- Detectable serum C-Reactive Protein
- At least 4 weeks since prior systemic therapy, radiotherapy, or surgery
- Must meet protocol lab criteria (adequate bone marrow, liver and renal function) to
be assessed at patient's first visit to the study center
Exclusion Criteria:
- Received any investigational drug within 30 days or 5 half-lives of the
investigational drug, whichever is longer
- History of receiving murine or human-murine recombination products, such as G250,
BE-8, and other monoclonal antibodies. (Note: Prior rituximab treatment is not an
exclusion criterion)
- Serious concurrent illness or significant cardiac disease characterized by
significant ischemic coronary disease or congestive heart failure
- Known HIV seropositivity, AIDS, hepatitis C or active hepatitis B infection. For
Cohort 7, known human herpesvirus-8 (HHV-8) seropositivity
- Presence of a transplanted solid organ (with the exception of a corneal transplant >
3 months prior to screening) or having received an allogeneic bone marrow transplant
or an allogeneic peripheral blood stem cell transplant |
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| Study is available at: |
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Seattle, WA
United States
Primary Contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email: info1@veritasmedicine.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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