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Recurrent Bladder CarcinomaPhase 1NCT03552796

sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer

A Phase 1 study testing Pharmacokinetic Study and Recombinant EphB4-HSA Fusion Protein in people with Recurrent Bladder Carcinoma and Bladder Cancer Stage 0, run by University of Southern California at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein (sEphB4-HSA), and to see how well it works in treating participants with bladder cancer that has come back or that isn't responding to bacillus Calmette-Guerin (BCG) vaccine treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Pharmacokinetic Study and Recombinant EphB4-HSA Fusion Protein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 1 Aug 2025
Phase
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with bladder CIS, or completely resected high grade Ta/T1 lesions that are BCG unresponsive; unresponsive is BCG refractory and/or BCG relapsing
  • BCG refractory: persistent high-grade disease at 6 months despite receiving at least 5-6 induction instillations and at least one maintenance (two of three instillations) in a 6 month period
  • BCG relapsing: recurrence of high-grade disease after achieving a disease-free state at 6 months after receiving at least 5-6 induction instillations and at least one maintenance (two of three instillations) in a 6 month period
  • Eastern Cooperative Oncology Group performance status 0 to 2
  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
  • NOTE: HIPAA authorization may be included in the informed consent or obtained separately
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  • Females must not be breastfeeding
  • Patients must be willing to undergo additional radiologic imaging while on study
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcl
  • Total bilirubin =< 1.5 X institutional upper limit of normal
  • 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 =< 1.5 X institutional upper limit of normal
  • 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, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Ability to understand and the willingness to sign a written informed consent
  • Absence of concomitant upper tract urothelial carcinoma (i.e. cancer within the kidney or ureter) as evidenced on computed tomography (CT) urogram and no visible lesion and/or biopsy proven evidence of urothelial carcinoma within the prostatic urethra (i.e. biopsy proven presence of cancer within the prostatic urethra)
  • Patient has a desire to preserve organ, understanding the risks of delaying standard of care
  • Patient is ineligible, declines, or is considered ineligible to undergo radical cystectomy

Who cannot join

  • If they are undergoing or have undergone in the past 4 weeks (28 days) any other therapy for their cancer, including radiation therapy and chemotherapy
  • If they have a major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
  • If they have untreated central nervous system (CNS) metastasis; patients whose CNS metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable may be enrolled in the dose escalation portion of the trial
  • If they have New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the patient at undue risk for treatment related complications
  • If they have any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient?s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
  • If they are pregnant or lactating
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  • If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
  • If they have had any active bleeding in the last =< 4 weeks or have an otherwise known bleeding diathesis
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to agent(s) or other agents used in study
  • 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 must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
  • Evidence of a history of a stroke or myocardial infarction within the last 6 months prior to study enrollment
  • Previous intravesical immunotherapy less than 3 months before study entry; Note: if a patient is eligible for the study but has had intravesical immunotherapy within the past 3 months, they can enroll in the study and initiation of treatment of the drug will be delayed until a minimum of 90 days has passed since the previous treatment
  • Renal and hepatic function values exceeding 2 times the upper normal value
  • Patients who cannot hold instillation for 2 hours
  • Patients who cannot tolerate intravesical dosing or intravesical surgical manipulation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: A First-in-Human Phase I Study of Intravesical sEphB4-HSA in Patients With "BCG-Unresponsive" Bladder Carcinoma In Situ (CIS), Completely Resected High Grade Ta/T1, to Establish the Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)

This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein (sEphB4-HSA), and to see how well it works in treating participants with bladder cancer that has come back or that isn't responding to bacillus Calmette-Guerin (BCG) vaccine treatment. sEphB4-HAS prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. Giving sEphB4-HSA may work better in treating participants with bladder cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the maximum tolerated dose (MTD) and recommended phase II dosing (RP2D) of intravesical sEphB4-HSA administration.

II. To describe the dose limiting toxicities and adverse event profile of intravesical sEphB4-HSA administration in patients with bladder carcinoma in situ (CIS) and/or high grade T1/Ta bladder cancer (BCa).

III. To describe the pharmacokinetics of intravesical sEphB4-HSA administration.

IV. To explore the anti-tumor activity of intravesical sEphB4-HSA administration as manifested by responses to treatment.

OUTLINE: This is a dose-escalation study.

Participants receive sEphB4-HSA intravesically over 2 hours on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 30 days, and again at 3 and 6 months.

Being tested
Pharmacokinetic Study, Recombinant EphB4-HSA Fusion Protein
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • Pharmacokinetic StudyOther

    Also called PHARMACOKINETIC, PK Study

    Correlative studies

  • Recombinant EphB4-HSA Fusion ProteinBiological

    Also called sEphB4-HSA

    Given intravesically

Study groups in NCT03552796
Study groupRoleWhat they receive
sEphB4-HSAExperimentalCohorts of at least 3 participants each will be treated with escalating doses of sEphB4-HAS at 25mg, 50 mg, 75mg, 100 mg, and 125 mg administered intravesically over 2 hours once a week for 6 consecutive weeks to determine the maximum tolerated dose (MTD) and recommended phase II dosing (RP2D). Cycle repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Other: Pharmacokinetic Study; Biological: Recombinant EphB4-HSA Fusion Protein

What is being measured

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

  1. Incidence of adverse events

    Adverse events will be evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: Up to 6 months

  2. Maximum tolerated dose (MTD) and recommended phase II dose (RP2D)

    The MTD is defined as the highest dose tested in which none or only one patient experienced DLT attributable to the study drug, when 6 patients were treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the study drug. The MTD will be the RP2D.

    Measured: Up to 6 months

Timeline

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

  1. First posted12 Jun 2018
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Why it stopped: Budget issues

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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552796
Sponsor's protocol ID
4B-16-3
Other IDs
NCI-2018-00818, 4B-16-3, P30CA014089
Status last verified
Jun 2023
First submitted
17 May 2018
Last updated
26 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pharmacokinetic Study and Recombinant EphB4-HSA Fusion Protein in people with Recurrent Bladder Carcinoma and Bladder Cancer Stage 0, run by University of Southern California 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 22 inclusion and 17 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: withdrawn, as of the sponsor's last update on 26 Jun 2023. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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 adverse events (time frame: Up to 6 months). The study lists 2 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 NCT03552796.

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 26 Jun 2023.

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