RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7) in treating patients with metastatic or unresectable solid tumors.
OBJECTIVES: Primary * Determine the maximum tolerated dose of therapeutic angiotensin-(1-7) in patients with metastatic or unresectable solid tumors. * Determine the pharmacokinetics of this drug in these patients. Secondary * Determine tumor response in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive therapeutic angiotensin-(1-7) subcutaneously on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of therapeutic angiotensin-(1-7) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first 3 weeks of study therapy. At least 6 patients are treated at the MTD. Blood samples are collected from patients after the first and fifth doses of the study drug for pharmacokinetic correlative studies. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
sequentially increasing doses 50-1000 mcg/kg
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Maximum tolerated dose
Time frame: 21 days
Toxicity
Time frame: 105 days
Response rate (complete or partial response) as measured by RECIST criteria
Time frame: 105 days
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