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Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors

Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00471562
Enrollment
18
Registered
2007-05-10
Start date
2007-03-31
Completion date
2009-10-31
Last updated
2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

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 treating patients with metastatic or unresectable solid tumors.

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.

Interventions

sequentially increasing doses 50-1000 mcg/kg

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Maximum tolerated dose21 days
Toxicity105 days

Secondary

MeasureTime frame
Response rate (complete or partial response) as measured by RECIST criteria105 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026