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 |
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.
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.
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
Winston-Salem, North Carolina 27103
(336) 716-2011
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