Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas
4 other identifiers
interventional
20
1 country
1
Brief Summary
This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking blood flow to the tumor. Funding Source - FDA Office of Orphan Drug Products (OOPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 9, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
January 30, 2014
CompletedJuly 5, 2018
July 1, 2018
3.3 years
March 9, 2012
November 15, 2013
July 2, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response
'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) among all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Approximately 1 year
Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
See the adverse event tables for specifics.
Approximately 1 year
Secondary Outcomes (3)
Time to Disease Progression
Approximately 5 years
Overall Survival
Approximately 5 years
Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)
Baseline and Day 22
Study Arms (1)
Treatment (antiangiogenesis therapy)
EXPERIMENTALPatients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
Interventions
Given SC
Eligibility Criteria
You may qualify if:
- Patients must have a histologically or cytologically confirmed sarcoma that is metastatic or unresectable and have progressed despite 1 or 2 prior treatment regimens with chemotherapy or targeted anti-cancer agents such as imatinib
- Prior treatment: \>= 4 weeks since completion of radiation or chemotherapy, except for \>= 6 weeks for Melphalan, nitrosoureas, or mitomycin-C
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Absolute neutrophil count \>= 1,500/Microliter (mcL)
- Platelets \>= 100,000/mcL
- Total bilirubin =\< 2 mg/dL
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \< 3 X upper limit or normal (ULN)
- Estimated (est.) creatinine clearance \> 30 mL/min
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as \> 10 mm
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Patients may not be receiving any other investigational agents for cancer treatment
- Patients with evidence of bleeding diathesis are ineligible
- No concurrent treatment with angiotensin-converting-enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs)
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or hypotension, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and nursing women are excluded from this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. William J. Petty
- Organization
- Wake Forest University Health Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
William Petty
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2012
First Posted
March 14, 2012
Study Start
October 1, 2009
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
July 5, 2018
Results First Posted
January 30, 2014
Record last verified: 2018-07