NCT02007005

Brief Summary

The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

8.1 years

First QC Date

December 5, 2013

Last Update Submit

May 5, 2015

Conditions

Superficial Bladder Cancer

Keywords

superficial bladder cancermistletoe extractmaximum tolerated dosemarker tumorremissionrecurrence rate

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation

    The primary objective is to investigate the maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation in patients with superficial bladder cancer. The treatment schedule included 6 weekly instillations.

    6 weeks

Secondary Outcomes (2)

  • Local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation

    6 weeks

  • Influence on remission and influence on the one year recurrence rate of abnobaVISCUM Fraxini for intravesical instillation

    up to 1 year

Study Arms (1)

Dose escalation

EXPERIMENTAL

intravesical instillation of abnobaVISCUM Fraxini

Drug: abnobaVISCUM Fraxini

Interventions

abnobaVISCUM FraxiniDRUG

intravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs

Also known as: viscum album extract, mistletoe extract, abnobaVISCUM
Dose escalation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinically proved superficial bladder cancer (Ta G1/G2 or T1G1/G2) 2 - 7 weeks before transurethral resection
  • Written informed consent for study participation and for documentation of disease data including further distribution of these data

You may not qualify if:

  • Muscle invasive bladder carcinoma and/or carcinoma in situ (CIS)
  • Intravesical instillation therapy within 6 months prior to study enrolment
  • Radiotherapy of the bladder prior to study enrolment
  • Contracted bladder (capacity less than 100 ml)
  • Non treated acute or chronic urinary tract infection
  • Allergy against mistletoe extract preparations
  • Subvesical obstructions (e. g. prostate hyperplasia, urethral stenosis, residual urine volume more than 80 ml)
  • Severe illnesses and circumstances not permitting study participation (e. g. alcoholism or substance abuse)
  • Pregnancy or lactation (pregnancy test if required) as well as women without sufficient contraception
  • Participation in another clinical study within 30 days prior to this study
  • Administration of immunotherapeutic and/or cytostatic drugs within 4 weeks prior to study enrolment
  • Chronic progressive infections (e. g. tuberculosis)
  • Pre-treatment with mistletoe extracts/mistletoe lectins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Theodor Bilharz Research Institute

Giza, 12411, Egypt

Location

Clinic of Urology of the University Hospital of Essen

Essen, 45122, Germany

Location

Related Publications (1)

  • Rose A, El-Leithy T, vom Dorp F, Zakaria A, Eisenhardt A, Tschirdewahn S, Rubben H. Mistletoe Plant Extract in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation Study. J Urol. 2015 Oct;194(4):939-43. doi: 10.1016/j.juro.2015.04.073. Epub 2015 Apr 22.

    PMID: 25910967RESULT

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

viscum album peptide

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Herbert Ruebben, Prof.Dr.Dr.

    Director of the Urological Clinic of the University Hospital Essen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

January 1, 2004

Primary Completion

February 1, 2012

Study Completion

September 1, 2013

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

EG(1)DE(1)