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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00471562
First received: May 8, 2007
Last updated: February 27, 2013
Last verified: June 2012
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: therapeutic angiotensin-(1-7)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: 105 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate (complete or partial response) as measured by RECIST criteria [ Time Frame: 105 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2007
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: therapeutic angiotensin-(1-7)
    sequentially increasing doses 50-1000 mcg/kg
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471562

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: W. Jeffrey Petty, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Publications:
Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00471562     History of Changes
Obsolete Identifiers: NCT01581268
Other Study ID Numbers: CDR0000543744, CCCWFU-99206, CCCWFU-99206/Ang 1-7, CCCWFU-IRB00001136
Study First Received: May 8, 2007
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Angiotensin I (1-7)
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014