Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Clinical Trial of Angiotensin 1-7 for Advanced 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced solid tumor meeting 1 of the
following criteria:
- Metastatic disease
- Unresectable disease
- Standard curative or palliative measures do not exist or are no longer effective
- Measurable or nonmeasurable disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan
- Nonmeasurable disease, defined as all other lesions, including small lesions
(i.e., ≥ 1 unidimensionally measurable lesion < 20 mm by conventional techniques
or < 10 mm by spiral CT scan) and truly nonmeasurable lesions, including any of
the following:
- Bone lesions
- Ascites
- Pleural or pericardial effusion
- Lymphangitis cutis or pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- No lung cancer with recent hemoptysis
- No brain metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 4 weeks
- No evidence of bleeding diathesis
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine clearance > 30 mL/min
- Bilirubin < 2 mg/dL
- AST and ALT < 3 times upper limit of normal
- No concurrent uncontrolled illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Uncontrolled hypertension or hypotension
- No psychiatric illness or social situation that would preclude informed consent or
study compliance
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior major surgery
- At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for melphalan,
nitrosoureas, or mitomycin C)
- No concurrent therapeutic anticoagulation
- No other concurrent investigational agents
- No concurrent angiotensin-converting enzyme inhibitors or angiotensin II receptor
blockers
- No concurrent combination antiretroviral therapy for HIV-positive patients
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Outcome Time Frame:
21 days
Safety Issue:
Yes
Principal Investigator
W. Jeffrey Petty, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000543744
NCT ID:
NCT00471562
Start Date:
March 2007
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
