Status:
COMPLETED
Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
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 tr...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00471562
Start Date
March 1 2007
End Date
October 1 2009
Last Update
August 1 2017
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096