Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2008-005428-99-GB
EUCTR2008-005428-99-GB
Active, not recruiting
Phase 1

A randomised controlled phase III trial comparing hyperthermia plus mitomycin to a second course of bacillus Calmette-Guerin or standard therapy in patients with recurrence of non-muscle invasive bladder cancer following induction or maintenance bacillus Calmette-Guerin therapy. - Hyperthermia plus mitomycin (HYMN)

niversity College London0 sites104 target enrollmentJuly 26, 2010
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionson muscle invasive bladder cancerMedDRA version: 9.1 Level: LLT Classification code 10005006 Term: Bladder cancer stage 0, with cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005007 Term: Bladder cancer stage 0, without cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005008 Term: Bladder cancer stage I, with cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005009 Term: Bladder cancer stage I, without cancer in situ
DrugsMitomycin CBCG (ImmuCyst and OncoTICE)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
on muscle invasive bladder cancer
Sponsor
niversity College London
Enrollment
104
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 26, 2010
End Date
October 7, 2016
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity College London

Eligibility Criteria

Inclusion Criteria

  • •Inclusion Criteria
  • •1\. Previous BCG induction or maintenance therapy for NMIBC.
  • •2\. Recurrence of disease following induction or maintenance BCG defined as;
  • •Grade 3 or grade 2 stage Ta or T1 disease.
  • •CIS with grade 3, grade 2 or grade 1 stage Ta or T1 disease
  • •Carcinoma in situ (CIS) alone
  • •3\. Have undergone a re\-resection of all T1 disease to exclude muscle invasive disease.
  • •4\. Age 18 yrs or older
  • •5\. WHO performance status 0, 1, 2, 3 or 4
  • •6\. Normal kidneys and ureters on imaging study within the past 12 months

Exclusion Criteria

  • •Exclusion criteria
  • •Patients with any of the following are not eligible for the trial:
  • •1\. Recurrence of grade 1 UCC withour CIS following BCG induction.
  • •2\. Previous intravesical chemotherapy in the past 6 months, other than single instillation post\-TUR.
  • •3\. UCC involving the prostatic urethra or upper urinary tract.
  • •4\. T2 or higher stage UCC
  • •5\. Known or suspected reduced bladder capacity (less than 250 mls)
  • •6\. Significant bleeding disorder.
  • •7\. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non\-hormonal contraception.
  • •8\. Current or long\-term use of oral corticosteroids, or patients with an immunocompromised state for any reason.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 1
A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone.infertilityTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
CTIS2024-513102-57-00Santiago Dexeus Font Fundacio Privada1,020
Recruiting
Phase 3
A randomized controlled phase III study comparing docetaxel, cisplatin and 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)
JPRN-UMIN000015107Japan Clinical Oncology Group (JCOG)240
Completed
Phase 3
Study to find out if restricting raw fruits in patients with blood cancer can reduce infections.Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C920- Acute myeloblastic leukemiaHealth Condition 3: null- Patients with acute lymphoblastic leukemia or acute myeloid leukemia
CTRI/2018/01/011418Cancer Institute200
Completed
Phase 3
Steroid tablets for preventing tiredness in cancer patients receiving chemotherapy medicine.Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C348- Malignant neoplasm of overlappingsites of bronchus and lung
CTRI/2018/08/015222Cancer Institute126
Not yet recruiting
Phase 3
To Study effectiveness of oral chemotherapy with low dose immunotherapy compared with chemotherapy in Head and Neck Cancer PatientsHealth Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
CTRI/2024/01/061661Tata Memorial Centre