Therapeutic Instillation of Mistletoe

NCT02106572 | Active Not Recruiting Phase 3

• 3 other identifiers: AB032013-003446-162023-503718-66-00
• Study Type: interventional
• Target: 548
• Locations: 2 countries
• Sites: 5

Brief Summary

The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM® 900, in particular, to compare the toxicity of the two treatments. Another secondary objective is the treatment efficacy as measured by calculated prognosis for recurrence and progression after 1 year, the tumor grading in case of a recurrence and by measurement of Quality of Life.

Conditions

Superficial Bladder Cancer

Keywords

superficial bladder cancer; viscum album extract; mistletoe extract; abnobaVISCUM; recurrence rate

Outcome Measures

Primary Outcomes (1)

• Time to tumor recurrence

  The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.

  up to two years

Secondary Outcomes (4)

• Toxicity and tolerability of the study medication

  up to two years

• Prognosis after 1 year for recurrence and progression

  1 year

• Quality of Life with the EORTC QLQ-C30 and BLS24 Quality of Life Questionnaires

  up to two years

• Tumor grading

  up to two years

Study Arms (2)

abnobaVISCUM 900

EXPERIMENTAL

intravesical instillation of abnobaVISCUM 900

Drug: abnobaVISCUM 900

Mitomycin C

ACTIVE COMPARATOR

intravesical instillation of Mitomycin C

Drug: Mitomycin C

Interventions

abnobaVISCUM 900 DRUG

intravesical instillation of abnobaVISCUM 900 13 times during treatment period

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

abnobaVISCUM 900

Mitomycin C DRUG

intravesical instillation of Mitomycin C 10 times during treatment period

Also known as: MMC, Mitomycin

Mitomycin C

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent for data protection and willingness to participate and comply with the study protocol prior to any study-related procedures
• Completely resected (detrusor muscle in the TUR specimen according to need) superficial bladder carcinoma (Stage Ta) with classification as intermediate-risk according to the EAU (update 2013) and one immediately post operative intravesical MMC 40 mg or Epirubicin 50 mg instillation, completed re-resection if indicated
• Karnofsky Performance Status of 50% to 100% (corresponding to Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2)
• Normal renal and liver function, normal cardiac and hematology profiles (patients with laboratory values slightly outside the reference range may be included, unless the investigator considers the abnormality as clinically significant)
• Female patients of childbearing potential must have a negative pregnancy test (β-human chorionic gonadotropin test) at Screening. Pregnancy during the treatment period including 12 weeks after the last instillation has to be excluded

You may not qualify if:

• Locally infiltrative or metastatic bladder tumor (Stage T2 or greater), low-risk Ta tumor (primary, solitary, LG/G1, \<3 cm, no CIS) or high-risk tumors according to EAU classification, update 2013 (T1; HG/G3; CIS; multiple and recurrent and large \[\>3 cm\] Ta G1/G2 tumors \[all conditions must be present at this point\], presence of upper urinary tract tumors or lesions which were not completely removed by TURB
• Urinary tract infection, benign prostatic obstruction grade II or III, neurogenic bladder, stress incontinence, bladder or urethral diverticula, fistulas or urethral stenosis
• Patients with acute systemic illness, such as inflammatory infections with fever \> 38°C
• Patients with previous recurrence of a superficial bladder cancer or radiotherapy of the bladder or other intravesical treatment within the last 6 months, or patients with previous mistletoe therapy
• Patients with other previous or co-existing malignancies or CIS
• Patients having any previous or concurrent therapy with a systemic chemo- / immunotherapeutical treatment regimen, in particular vinca alkaloids, bleomycine and doxorubicine, or patients who are treated with pyroxidine hydrochloride (vitamin B6)
• Untreated coagulation disorders or inadequate anticoagulation therapy
• Leukocyte count \< 4,000/mm3 or platelet count \< 100,000/mm3
• Serum creatinine \> 1.7 mg/dL
• Patients with known hypersensitivity to the excipients of the study medication (monosodium phosphate, disodium phosphate, ascorbic acid)
• Patients with a known hypersensitivity to mistletoe products and MMC
• Patients who were administered within a 4-week period before Visit 1 any other experimental drug under investigation
• Male patients planning to father a child or sperm donation from the first administration of study medication until 3 months after the last administration of the study medication
• Patients with a history of alcohol and / or drug abuse
• Patients who are unable to be regularly observed, not permitting adequate follow-up and compliance to the protocol

Sponsors & Collaborators

• Abnoba Gmbh: lead

Study Sites (5)

Theodor Bilharz Research Institute

Giza, 12411, Egypt

Location

Clinic of Urology of the University Hospital of Essen

Essen, 45122, Germany

Location

Urologische Gemeinschaftspraxis

Heinsberg, 52525, Germany

Location

Urologische Praxis

Herzberg, 37412, Germany

Location

Urologische Facharztpraxis

Würselen, 52146, Germany

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

viscum album peptide; Mitomycin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jochen Hess, Prof. Dr.

  Chief Medical Officer of the Urological Clinic of the University Hospital Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind Review in accordance with with ICH-Biostatistics Guideline ICH E9
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2015
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 23, 2025

Record last verified: 2024-02

Locations

DE (4); EG (1)