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Male Breast CancerEarly Phase 1NCT02013492

Propranolol Hydrochloride in Treating Patients With Locally Recurrent or Metastatic Solid Tumors That Cannot Be Removed By Surgery

A Early Phase 1 study testing propranolol hydrochloride and Correlative Studies in people with Male Breast Cancer and Recurrent Melanoma, run by William Carson at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
propranolol hydrochloride and Correlative Studies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
21 Jan 2014to 12 Jun 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically-proven locally-recurrent or metastatic solid tumor; the first 10 patients may have cancer of any histology; preference will be given to patients with metastatic ovarian cancer, breast cancer, and malignant melanoma, as these malignancies have been shown to be sensitive to manipulation of the beta-adrenergic receptor; the final twenty-five patients to be accrued must have locally-recurrent or metastatic malignant melanoma that is not surgically resectable. An additional cohort of 10 patients with BCLC stages A to C locally advanced or metastatic hepatocellular carcinoma (HCC) that is not surgically resectable will also be enrolled (See appendix for BCLC staging system). Patients with liver transplantation will not be eligible.
  • The diagnosis of hepatocellular carcinoma may be made by one of the following methods:
  • Pathologically (histologically or cytologically) proven diagnosis of HCC.
  • At least one solid liver lesion or vascular tumor thrombosis (involving portal vein, IVC and/or hepatic vein) > 1 cm with arterial enhancement and delayed washout on multiphasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis.
  • For patients whose CURRENT disease is vascular only: Enhancing vascular thrombosis (involving portal vein, IVC and/or hepatic vein) demonstrating early arterial enhancement and delayed washout on multi-phasic CT or MRI, in a patient with known HCC (diagnosed according to criteria in (a) or (b).
  • Patients may have had any number of prior systemic therapies; patients need not have exhausted standard therapy for their disease, but must be stable and must not have actively progressing
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  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Karnofsky >= 60%
  • Life expectancy of greater than 6 months
  • Patients (except for the HCC cohort) must have normal organ and marrow function as defined below:
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
  • Creatinine within normal institutional limits OR
  • Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Parameters for the HCC cohort:
  • leukocytes > or = 3000/mcl
  • absolute neutrophil count > or =1000/mcl
  • platelets > or = 70,000
  • total bilirubin < or = 2mg/dL
  • AST/ALT <6 times ULN
  • creatinine within normal institutional limits OR
  • creatinine clearance > or = 60mL/min/1.73m2 for patients with creatinine levels above institutional normal level
  • INR < or = 1.7
  • The effects of propranolol on the developing human fetus may be detrimental. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients with brain metastases may participate in this clinical study provided that symptoms have been controlled with standard therapies and/or appropriate medications; the principal investigator (P.I.) will carefully evaluate the suitability of patient participation when brain metastases are present

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to propranolol
  • Uncontrolled hypertension
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with significant lung disease, an ejection fraction less than 40%, or a resting heart rate less than 60/min will not be enrolled
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  • Pregnant women are excluded from this study because propranolol is an agent with the potential for teratogenic or abortifacient effects
  • Patients who are currently receiving a beta-blocker for another medical condition will be excluded from this study; patients with extremes of blood pressure (e.g., systolic blood pressure [SBP] > 150 or < 100) may be excluded from participation if the treating physician feels that this medical condition has not been adequately addressed by the patient's primary care physician
  • Patients with worsening depression that has not been addressed clinically will be excluded from this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Pilot Study of Beta-Blockers in Patients With Advanced Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
propranolol hydrochloride, Correlative Studies
Keywords
Beta-Blocker, metastatic melanoma, hepatocellular carcinoma
Medical subject headings
Breast Neoplasms, Male, Melanoma, Breast Neoplasms, Carcinoma, Ovarian Epithelial, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • propranolol hydrochlorideDrug

    Also called Inderal

    Given PO

  • Correlative StudiesOther

    Correlative studies will be conducted using the following materials:

    • Plasma derived from peripheral blood.
    • Peripheral blood mononuclear cells (PBMC) derived from patient blood
    • Tumor tissue obtained at the time of core needle biopsy at the 2 month time point.
    • Paraffin-embedded tumor tissue obtained pre-therapy to make the diagnosis of metastatic disease.
Study groups in NCT02013492
Study groupRoleWhat they receive
Treatment (propranolol hydrochloride)ExperimentalPatients receive propranolol hydrochloride PO BID for 4 months in the absence of disease progression or unacceptable toxicity. Propranolol will be administered on an out-patient basis. Blood for correlative studies (30 ml - green top tube) will be drawn at baseline and at each clinic visit. Tumor tissue for analysis will be obtained via core needle biopsy (or other appropriate modality) pre-study and at approximately the two month time point.
Receives: Drug: propranolol hydrochloride; Other: Correlative Studies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) V. 4.0

    A dose-limiting toxicity (DLT) will be considered as any grade 3 or higher hematologic or non- hematologic toxicity that is probably or definitely related to treatment.

    Measured: Up to 4 months

  2. Change in vascular endothelial growth factor (VEGF)

    Measured: Baseline to 4 months

  3. Effect of beta-adrenergic blockade on the tumor microenvironment

    Measured via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells.

    Measured: Up to 4 months

  4. Effect of beta-adrenergic blockade on the host immune system

    Measured via a series of correlative laboratory studies using cancer tumor tissue and peripheral blood mononuclear cells.

    Measured: Up to 4 months

Secondary outcomes (2)

  1. Progression-free survival

    Measured: Up to 1 year

  2. Overall survival

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2013 (estimated)
  2. Study start21 Jan 2014
  3. Primary completion12 Jun 2015
  4. Study completion12 Jun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02013492
Sponsor's protocol ID
OSU 13023
Other IDs
NCI-2013-01958
Status last verified
Dec 2022
First submitted
11 Dec 2013
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing propranolol hydrochloride and Correlative Studies in people with Male Breast Cancer and Recurrent Melanoma, run by William Carson at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) V. 4.0 (time frame: Up to 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02013492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.

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