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

NCT00471562 | Completed Phase 1 FDA Drug

• 4 other identifiers: CDR0000543744CCCWFU-99206CCCWFU-99206/Ang 1-7CCCWFU-IRB00001136
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  21 days

• Toxicity

  105 days

Secondary Outcomes (1)

• Response rate (complete or partial response) as measured by RECIST criteria

  105 days

Interventions

therapeutic angiotensin-(1-7) BIOLOGICAL

sequentially increasing doses 50-1000 mcg/kg

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Related Publications (1)

• Petty WJ, Miller AA, McCoy TP, Gallagher PE, Tallant EA, Torti FM. Phase I and pharmacokinetic study of angiotensin-(1-7), an endogenous antiangiogenic hormone. Clin Cancer Res. 2009 Dec 1;15(23):7398-404. doi: 10.1158/1078-0432.CCR-09-1957. Epub 2009 Nov 17.

  PMID: 19920106 RESULT

MeSH Terms

Interventions

angiotensin I (1-7)

Study Officials

• W. Jeffrey Petty, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 1, 2017

Record last verified: 2012-06

Locations

US (1)