Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-27 @ 2:06 PM
Study NCT ID:
NCT02013492
Status:
COMPLETED
Last Update Posted:
2022-12-06
First Post:
2013-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propranolol Hydrochloride in Treating Patients With Locally Recurrent or Metastatic Solid Tumors That Cannot Be Removed By Surgery
Sponsor:
William Carson
Organization:
Study Overview
Official Title:
A Pilot Study of Beta-Blockers in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot trial studies propranolol hydrochloride in treating patients with locally recurrent or metastatic solid tumors that cannot be removed by surgery. Propranolol hydrochloride may slow the growth of tumor cells by blocking the use of hormones by the tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the feasibility and tolerability of beta-adrenergic blockade in patients with metastatic or locally advanced cancer.
II. To determine the effects of beta-adrenergic blockade on the tumor microenvironment and host immune system via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells from the study patients.
SECONDARY OBJECTIVES:
I. Evaluate the effects of beta-adrenergic blockade on progression-free survival and overall survival.
OUTLINE:
Patients receive propranolol hydrochloride orally (PO) twice daily (BID) for 4 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
I. To determine the feasibility and tolerability of beta-adrenergic blockade in patients with metastatic or locally advanced cancer.
II. To determine the effects of beta-adrenergic blockade on the tumor microenvironment and host immune system via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells from the study patients.
SECONDARY OBJECTIVES:
I. Evaluate the effects of beta-adrenergic blockade on progression-free survival and overall survival.
OUTLINE:
Patients receive propranolol hydrochloride orally (PO) twice daily (BID) for 4 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01958 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |