Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00471562|
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : August 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: therapeutic angiotensin-(1-7)||Phase 1|
- 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.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Biological: therapeutic angiotensin-(1-7)
- Maximum tolerated dose [ Time Frame: 21 days ]
- Toxicity [ Time Frame: 105 days ]
- Response rate (complete or partial response) as measured by RECIST criteria [ Time Frame: 105 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471562
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||W. Jeffrey Petty, MD||Wake Forest University Health Sciences|