Trial Information

A Phase 1 Study of Multiple Intravenous Administrations of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease

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.