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

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00471562
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-05-08
• Study First Submitted QC: 2007-05-08
• Study First Posted: 2007-05-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2012-06
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity	105 days
Maximum tolerated dose	21 days

Secondary Outcome Measures

Name	Time	Method
Response rate (complete or partial response) as measured by RECIST criteria	105 days

Trial Locations

Locations (1)

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States