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Cancer Vaccine
BCG + Gemcitabine for Relapsed Bladder Cancer
Phase 1 & 2
Recruiting
Led By Eugene Pietzak, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status ≥60%
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test if BCG and gemcitabine are safe and effective when used together to treat BCG-relapsing bladder cancer.
Who is the study for?
This trial is for adults with high-grade non-muscle invasive bladder cancer that has returned after BCG treatment. Participants must have had all visible tumors removed recently, no upper urinary tract cancer in the last year, and a good performance status. Pregnant individuals, those with BCG contraindications or severe reactions to it, active tuberculosis, immune deficiencies, muscle-invasive or metastatic urothelial carcinoma are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining Bacillus Calmette-Guérin (BCG) with increasing doses of Gemcitabine in treating bladder cancer that's come back after BCG therapy. The goal is to find the highest dose of Gemcitabine that works well with BCG and causes few or mild side effects.See study design
What are the potential side effects?
Potential side effects include irritation at the injection site from BCG and typical chemotherapy-related issues from Gemcitabine such as nausea, low blood counts leading to infection risk or bleeding problems, fatigue, fever due to immune response activation by BCG.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
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I am 18 years old or older.
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My bladder cancer has returned within 2 years after BCG treatment.
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My cancer's type and stage have been confirmed by MSK's Pathology Department.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
evaluate the MTD (Phase I)
Disease
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bacillus Calmette-Guérin (BCG) and GemcitabineExperimental Treatment2 Interventions
Eligible patients will receive combination intravesical chemoimmunotherapy. Treatment is sequential, with twice-weekly intravesical gemcitabine given at weeks 1, 4, 7, and 10, for a total of 8 doses, administered in a standard fashion. In phase I, the dose of gemcitabine will depend on the dose level being assessed for the determination of the MTD. phase II, 1 dose level will be given (the MTD from phase I). Fixed doses of once-weekly intravesical BCG therapy (TICE strain, 50 mg) will be given at weeks 2 (+/- 2 days), 3 (+/- 2 days), 5 (+/- 2 days), 6 (+/- 2 days), 8 (+/- 2 days), and 9 (+/- 2 days), for a total of 6 doses, also administered in a standard fashion. All intravesical therapy will be administered in the chemotherapy suite on an outpatient basis, in accordance with standard clinical practice. Intravesical therapies will be retained in the bladder for up to 2 h (BCG) or 1 h (gemcitabine), or as tolerated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bacillus Calmette-Guérin (BCG)
2014
Completed Phase 2
~1980
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,742 Total Patients Enrolled
Eugene Pietzak, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to areas like the urethra, ureter, or renal pelvis.I can care for myself but may need occasional help.I have or am being treated for advanced bladder cancer.I am 18 years old or older.My bladder cancer has returned within 2 years after BCG treatment.My bladder cancer did not respond to BCG treatment after receiving most of the doses.I had a surgery to check the spread of bladder cancer into deeper layers.My cancer's type and stage have been confirmed by MSK's Pathology Department.I am immunosuppressed due to a condition or treatment, not including topical or inhaled steroids.My bladder cancer came back after completing most of my BCG therapy.You have known reasons why you should not receive BCG treatment.You have had a severe allergic reaction in the past or a strong reaction to a BCG vaccine.I haven't had bladder cancer in the kidney or ureter in the last year.I do not have a fever or ongoing visible blood in my urine.All visible growths were removed from my body within the last 60 days.I have active tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: Bacillus Calmette-Guérin (BCG) and Gemcitabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional participants being taken into this clinical trial at present?
"Affirmative. The clinical trial is actively recruiting and the data hosted on clinicaltrials.gov confirms this information. Initially posted on November 22nd 2019, the study was most recently updated-on December 1st 2022 -and seeks 68 candidates from 8 different medical centres."
Answered by AI
How many participants are being included in this medical experiment?
"Affirmative. The clinical trial's presence on the website of clinicaltrials.gov indicates that it is presently recruiting patients, with 68 participants sought out from 8 different sites since its post date of November 22nd 2019 and last update on December 1st 2022."
Answered by AI
For what illnesses is gemcitabine commonly prescribed?
"Typically, gemcitabine is employed to fight small cell lung cancer (sclc). However, head and neck carcinoma, advanced stages of pancreatic adenocarcinoma cervical cancers are also treatable with this medication."
Answered by AI
Have there been other tests conducted using Gemcitabine?
"At the moment, 446 investigations into gemcitabine are ongoing with 134 of those trials at Phase 3. Out of a whopping 24,565 locations conducting these studies worldwide, several sites for Gemcitabine can be found in Woolloongabba Queensland."
Answered by AI
Where are the current sites where this investigation is taking place?
"This trial is currently accessible at 8 medical sites, including Basking Ridge, Hartford and New york. Participants are encouraged to select the site most proximal to them in order to minimize travel needs."
Answered by AI
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