Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors
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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 |
- Maximum tolerated dose [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: 105 days ] [ Designated as safety issue: Yes ]
- 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) |
-
Biological: therapeutic angiotensin-(1-7)
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 |
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| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| 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 May 16, 2013