Clinical trial NCT01878188: Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma
Official title: Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Transitional Cell Carcinoma of Bladder
Keywords: inodiftagene vixteplasmid
Lead sponsor: Anchiano Therapeutics Israel Ltd.
Sponsor class: INDUSTRY
First posted: 2013-06-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs)
* Recurrence after treatment with BC-819/PEI and BCG
* Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder
* After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly


Eligibility criteria: Inclusion Criteria:

1. Patients with superficial papillary transitional cell carcinoma of the bladder for whom BCG is clinically indicated. If CIS is present, diagnosis needs to be confirmed by biopsy prior to the start of the study.
2. Males or females more than 18 years old
3. All papillary tumors must be resected within 8 weeks prior to the start of study therapy.
4. ECOG performance status 2 or less.
5. Adequate hematologic function, as demonstrated by

   1. Hemoglobin 10 g/dL or higher
   2. ANC 1.5 x 109/L or higher
   3. Platelets higher than 100 x 109/L
6. Adequate liver and renal function as demonstrated by

   1. AST and ALT each 3.0 x ULN or less
   2. Total bilirubin 1.5 x ULN or less
   3. Creatinine 1.5 X ULN OR less, creatinine clearance \>60 mL/min
7. If fertile and sexually active, must use adequate contraception
8. Must be able to comply with protocol requirements, including attendance at required clinic visits.
9. Patients must provide written informed consent.

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Exclusion Criteria:

1. Patients who are candidates for either partial or total bladder resection, unless either medically contraindicated or who have refused surgery.
2. Patients with a tumor in a diverticulum, in the prostatic urethra, or covering the ureteral orifice.
3. Patients who have received cytotoxic drugs, systemic corticosteroids or any investigational drug for any indication within 4 weeks of the start of protocol treatment.
4. Patients who have received any intravesical therapy other than surgical resection within 8 weeks prior to the start of protocol treatment.
5. Patients who have received radiation therapy for bladder cancer at any time or for any condition within 4 months prior to the start of protocol treatment.
6. Patients who have active infections, including urinary tract infections, whether viral, bacterial or fungal and requiring therapy.
7. Patients who are receiving coumadin.
8. Patients who have had to discontinue a past course of BCG due to toxicity.
9. Patients who are having urinary tract signs or symptoms from recent urinary tract procedures or manipulations, such as biopsies or catheterizations.
10. Patients who are known to be HIV positive.
11. Females who are pregnant or breast feeding.
12. Presence of any medical, psychological or social condition or situation which may, in the investigator's opinion, make it difficult for the patient to tolerate study medication or comply with study procedures and other requirements. This includes but is not limited to active infections, poorly controlled diabetes, uncontrolled cardiac arrhythmias, angina pectoris, or hypertension.

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Primary outcomes:
measure: Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG by number of subjects with AEs and change from baseline for clinical safety laboratory tests
timeFrame: 3 months
Secondary outcomes:
measure: Recurrence of bladder cancer after treatment with BC-819/PEI and BCG
timeFrame: 3 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion MC
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Medical Center
city: Kfar Saba
country: Israel
facility: Meir MC
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Wolfson Medical Center
name: Ami Sidi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bnai-Zion Medical Center, Haifa, Israel
name: Sarel Halachmi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center, Kfar-Saba, Israel
name: Ilan Leibovitch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Ein Karem Medical Center
name: Ofer Gofrit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf Harofe Medical Center
name: Amnon Zisman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carmel Hospital,Haifa
name: Abraham Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv Medical Center
name: Haim Matzkin, MD
role: PRINCIPAL_INVESTIGATOR
References: