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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vasodilator Agents

ClinicalTrials.gov processed this record on August 28, 2014