Sarcoma Clinical Trial
Official title:
A Phase I Investigation of IL-12/Pulse IL-2 in Adults With Advanced Solid Tumors
The purposes of this study are fourfold. It will 1) determine what dose of interleukin-12
(IL-12) and interleukin-2 (IL-2) combination therapy can be given safely to patients with
advanced cancer; 2) evaluate the side effects of this treatment; 3) examine how the body
handles this drug combination; and 4) determine whether and how the therapy may cause the
immune system to stop or slow tumor growth.
IL-2 is an approved drug for treating melanoma and kidney cancer. IL-12 is an experimental
drug that has shown anti-cancer activity in animals, shrinking tumors and slowing their
growth. Animal studies suggest that given together, the drugs may be more effective against
cancer than either one singly.
Patients 18 years of age and older with advanced solid-tumor cancers (kidney, breast, lung,
sarcomas and others) that do not improve with standard treatment may qualify for this study.
Candidates will have a physical examination, including blood and urine tests,
electrocardiogram (EKG) and echocardiogram, DTH skin test (to test the function of the immune
system), chest X-ray and lung function tests to determine eligibility. Bone marrow biopsy and
imaging procedures such as CT and MRI scans may also be required. Patients over 50 years old
will also undergo exercise stress testing.
Treatment will consist of four courses of IL-2 and IL-12. On days one and nine of each
course, patients will receive three doses (one every 8 hours) of IL-2 intravenously (through
a vein). On days two, four, six, 10, 12 and 14, they will receive IL-12 intravenously. This
will be followed by a recovery period from days 15 through 35. This regimen will be repeated
for another three cycles; patients who show benefit without severe side effects may continue
for additional cycles. Treatment for the first cycle will be administered in the hospital. If
the drugs are well tolerated, additional therapy may be given on an outpatient basis.
A biopsy (removal of a small sample of tumor tissue) will be done at the beginning of the
study, after completing the first treatment cycle, and possibly again when the cancer slows,
stops or gets worse, or if the patient leaves the study. These tumor samples will be examined
to evaluate the effects of treatment. Several blood samples also will be collected during the
course of treatment to monitor immune system effects. A device called a heparin lock may be
put in place to avoid multiple needle sticks.
...
Background:
Renal cell cancer responds to treatment with a variety of antiangiogenic and immunomodulatory
drugs.
In the RENCA model of renal cell cancer the combination of IL-12 and pulse IL-2 cures 88-100%
of mice with established tumors.
The tumor regression observed in this model is due to both antiangiogenic and immunologic
effects.
Objective:
To define the maximum tolerated dose and dose-limiting toxicities of recombinant human IL-12
administered intravenously in combination with intermittent pulse recombinant human IL-2 in
adults with various advanced and/or refractory solid tumors.
To evaluate the pharmacokinetics of intravenous rhIL-12/pulse rhIL-2 administration in adults
with various advanced and/or refractory solid tumors.
To provide a preliminary assessment of the ability of rhIL-12/pulse rhIL-2 to modify
neovascularization and gene expression in the local tumor site, and to induce a measurable
antitumor effect in adults with various advanced and/or refractory solid tumors.
To evaluate the immunomodulatory activity of combined systemic administration of
rhIL-12/pulse rhIL-2.
Eligibility:
Patients with advanced solid tumors for whom a proven more effective therapy does not exist.
Patients with renal cell cancer will be required to have received sunitinib or sorefinib or
refused this option.
The patient must have normal organ function and a life expectancy of at least 12 Weeks.
Normal pulmonary function (as documented by PFTs), and for patients over the age of 50,
normal stress thallium testing.
No prior treatment with IL-12.
Design:
Phase I dose escalation with an expansion cohort of 10 patients treated at the maximum
tolerated dose.
Patients will be hospitalized for treatment. IL-2 will be given intravenously every 8 hours
on day 1 and this will be followed by intravenous administration of IL-12 every other day for
three doses on days 2, 4, and 6. After two days of rest the schedule will be repeated. Cycles
will be repeated every 36 days.
Tumor response will be evaluated after every treatment. Stable or responding patients will
continue treatment with evaluations after every cycle of treatment.
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