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JOURNAL ONKOLOGIE – STUDIE
TIM

Therapeutic Instillation of Mistletoe

Rekrutierend

NCT-Nummer:
NCT02106572

Studienbeginn:
April 2015

Letztes Update:
13.02.2024

Wirkstoff:
abnobaVISCUM 900, Mitomycin C

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Abnoba Gmbh

Collaborator:
-

Studienleiter

Jochen Hess, Prof. Dr.
Principal Investigator
Chief Medical Officer of the Urological Clinic of the University Hospital Essen

Kontakt

Studienlocations
(3 von 5)

Alle anzeigen

Studien-Informationen

Detailed Description:

This is a randomized, open-label, active-controlled, prospective, multinational Phase III

confirmative study with 2 treatment groups and an adaptive design (Bauer and Köhne, 1994).

The study is designed to compare the efficacy of treatment with abnobaVISCUM® 900 with

Mitomycin C (MMC). Patients with completely resected superficial bladder carcinoma (Stage Ta)

with an intermediate risk classification according to the European Association of Urology

(EAU, update 2013) and with one immediately post operative MMC 40 mg or Epirubicin 50 mg

intravesical instillation will be eligible for inclusion in the study.

The study comprises a screening period of not more than 6 weeks, a treatment period of 12

months for abnobaVISCUM® 900 and MMC and a follow-up period of 12 months. Patients will be

screened within 6 weeks after the transurethral resection of the bladder (TURB) and the

immediately post operative MMC 40 mg or Epirubicin 50 mg intravesical instillation. A

re-resection should be performed before inclusion if indicated. Every patient is to provide

written informed consent before any study related procedures will be performed.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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)

- Life expectancy of ≥ 2 years at the time point of study inclusion

- 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

Exclusion Criteria:

- 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

- Male patients unwilling to use barrier contraception ie, condoms and spermicide, from

the day of first administration of the study medication until 12 weeks after

administration of the study medication. In case the sexual relation is restricted to

women fulfilling one of the criteria listed under inclusion criteria for female

patients the barrier contraception is not necessary.

- 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

Studien-Rationale

Primary outcome:

1. Time to tumor recurrence (Time Frame - up to two years):
The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.



Secondary outcome:

1. Toxicity and tolerability of the study medication (Time Frame - up to two years):
The secondary objective, namely safety including toxicity and tolerability of the study medication, will be assessed by the monitoring of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE), laboratory assessments (hematology, biochemistry and urinalysis) and a global judgment of tolerability.

2. Prognosis after 1 year for recurrence and progression (Time Frame - 1 year):
A secondary efficacy endpoint is prognosis after 1 year for recurrence and progression, estimated by the European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculator.

3. Quality of Life with the EORTC QLQ-C30 and BLS24 Quality of Life Questionnaires (Time Frame - up to two years):
A secondary efficacy endpoint is measurement of Quality of Life with the EORTC QLQ-C30 and BLS24 questionnaires.

4. Tumor grading (Time Frame - up to two years):
A secondary efficacy endpoint is the tumor grading in case of a recurrence by cytology, ultrasound, and cystoscopy.

Studien-Arme

  • Experimental: abnobaVISCUM 900
    intravesical instillation of abnobaVISCUM 900
  • Active Comparator: Mitomycin C
    intravesical instillation of Mitomycin C

Geprüfte Regime

  • abnobaVISCUM 900 (viscum album extract / mistletoe extract / abnobaVISCUM / ):
    intravesical instillation of abnobaVISCUM 900 13 times during treatment period
  • Mitomycin C (MMC / Mitomycin / ):
    intravesical instillation of Mitomycin C 10 times during treatment period

Quelle: ClinicalTrials.gov


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