- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00471562
Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors
Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose
Time Frame: 21 days
|
21 days
|
Toxicity
Time Frame: 105 days
|
105 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (complete or partial response) as measured by RECIST criteria
Time Frame: 105 days
|
105 days
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: W. Jeffrey Petty, MD, Wake Forest University Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000543744
- CCCWFU-99206
- CCCWFU-99206/Ang 1-7
- CCCWFU-IRB00001136
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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