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Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer

Primary Purpose

Superficial Bladder Cancer

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

abnobaVISCUM Fraxini

About this trial

This is an interventional treatment trial for Superficial Bladder Cancer focused on measuring superficial bladder cancer, mistletoe extract, maximum tolerated dose, marker tumor, remission, recurrence rate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Theodor Bilharz Research Institute
Clinic of Urology of the University Hospital of Essen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose escalation

Arm Description

intravesical instillation of abnobaVISCUM Fraxini

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Secondary objectives are to investigate the local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation. Main variables of safety analysis are adverse events, vital signs and clinical laboratory tests.

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

Secondary objectives are to investigate the influence on remission and influence on the one year recurrence rate measured by histological examination of biopsies of the marker lesion, cytology and cystoscopy.

Full Information

NCT ID

NCT02007005

First Posted

December 5, 2013

Last Updated

May 5, 2015

Sponsor

Abnoba Gmbh

1. Study Identification

Unique Protocol Identification Number

NCT02007005

Brief Title

Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer

Official Title

Dose-Escalation-Study With abnobaVISCUM® Fraxini 2 (AVF2) as Intravesical Instillation in Patients With Superficial Bladder Cancer According to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) - Guidelines: a Phase Ib/IIa Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abnoba Gmbh

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

A dose-escalation-study according ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) with different concentrations of abnobaVISCUM® Fraxini is conducted in two hospitals in Germany and Egypt. Patients with superficial bladder cancer TaG1/G2 or T1G1/G2 are enclosed after TUR-B (transurethral resection bladder). The tolerability of the different concentrations is assessed after weekly instillations into the urinary bladder for 6 weeks. A direct antitumoral effect is assessed on a single marker tumor left in the bladder after a complete TUR of all other lesions according a study design established by the EORTC-GENITO-URINARY GROUP (European Organisation for Research and Treatment of Cancer). A re-TUR is conducted after 12 weeks. Tumor response is measured by biopsy of the marker lesion and by cytology. Safety of the instillations is measured by analysis of adverse events, vital signs and clinical laboratory tests. After treatment of a cohort is finished a safety evaluation is conducted to decide about the increase to the next dosage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Superficial Bladder Cancer

Keywords

superficial bladder cancer, mistletoe extract, maximum tolerated dose, marker tumor, remission, recurrence rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose escalation

Arm Type

Experimental

Arm Description

intravesical instillation of abnobaVISCUM Fraxini

Intervention Type

Drug

Intervention Name(s)

abnobaVISCUM Fraxini

Other Intervention Name(s)

viscum album extract, mistletoe extract, abnobaVISCUM

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

6 weeks

Title

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

Description

Time Frame

up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Herbert Ruebben, Prof.Dr.Dr.

Organizational Affiliation

Director of the Urological Clinic of the University Hospital Essen

Official's Role

Study Director

Facility Information:

Facility Name

Theodor Bilharz Research Institute

City

Giza

ZIP/Postal Code

12411

Country

Egypt

Facility Name

Clinic of Urology of the University Hospital of Essen

City

Essen

ZIP/Postal Code

45122

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25910967

Citation

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.

Results Reference

result

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Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer

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