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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:8/2/2017
Start Date:March 2007
End Date:October 2009

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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.

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.

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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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mi
from
Winston-Salem, NC
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