Mechanism of Action Trial of ColoAd1
Conditions
Resectable Colon Cancer - Resectable Non-small Cell Lung Cancer - Resectable Bladder Cancer - Resectable Renal Cell Carcinoma
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Carcinoma, Renal Cell
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Colo-Ad1
Type: Biological
Overall Status
Recruiting
Summary
To assess the pattern of ColoAd1 viral delivery and viral expression within colon tumour tissue when administered by intra-tumoural injection or within colon, non-small cell lung, bladder and renal cell tumour tissues following ColoAd1 administration by intravenous infusion.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion criteria:

Patients must meet all the following criteria to be eligible for participation:

- Able and willing to provide written informed consent and to comply with the study protocol

- Age ≥ 18 years

- Patients with histologically confirmed resectable colon cancer, NSCLC (squamous and non-squamous), bladder cancer (urothelial cell carcinoma) or RCC (renal cell carcinoma), scheduled for resection of primary tumour and with planned resection of draining lymph nodes for colon cancer

- Diagnostic colonoscopy performed at the study centre (Cohorts A and B only) or a referral centre (Cohort B only) and a report from this colonoscopy available for the study

- Tumour size of 3 cm or more in diameter as estimated during diagnostic colonoscopy for cohorts A and B or by CT-scan for cohorts C, D and E.

- At least 2 weeks since the last dose of any intravenous systemic chemotherapy at time of first administration of ColoAd1

- Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.

- Able to undergo surgery with general anaesthesia

- Surgery planned and administration of ColoAd1 feasible within

- 15 days of planned surgery (following IT administration or following first dose of IV administration) for cohorts A and B

- 10 - 25 days of first ColoAd1 administration for cohorts C, D and E

- ECOG Performance Status Score of 0 or 1

- Adequate renal function

- Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ≥ 60 mL/min, or measured creatinine clearance ≥60 mL/min,

- Absence of clinically significant haematuria on urinalysis: dipstick < 2+

- Absence of clinically significant proteinuria on urinalysis: dipstick < 2+.

- Adequate hepatic function

- serum bilirubin <1.5 x ULN

- AST and ALT ≤ 3 x ULN

- Adequate bone marrow function:

- ANC ≥ 1.5 x 109/L,

- platelets ≥ 100 x 109/L,

- haemoglobin ≥ 90 g/L

- Adequate coagulation tests: INR ≤ 1.5 x ULN;

- For females of childbearing potential (defined as <2 years after last menstruation or not surgically sterile), a negative pregnancy test must be documented prior to enrolment;

- For women who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year (e.g., hormonal implants, combined oral contraceptives, vasectomized partner), during the treatment period and for at least 3 months after the last dose of study drug;

- For men: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria for all patients:

Patients who meet any of the following criteria are not eligible for enrolment:

- Rectal tumours; (cohorts A and B);

- An obstructive tumour of the intestine (cohorts A and B only) or of the urinary tract (cohort D);

- Any condition necessitating surgery in less than 8 days (cohorts A or B) or 10 days (cohorts C, D or E);

- Pregnant or lactating (nursing) women;

- Known and/or a history or evidence of significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids at doses higher than dexamethasone 10 mg or equivalent, or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks);

- Splenectomy

- Prior allogeneic or autologous bone marrow or organ transplantation

- Active infections requiring antibiotics, physician monitoring, or recurrent fevers >38.0 degrees centigrade associated with a clinical diagnosis of active infection

- Active viral disease, positive serology for HIV, hepatitis B or hepatitis C

- Use of the following anti-viral agents:

- ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to day 1;

- or PEG-IFN (within 14 days prior to day 1);

- Administration of an investigational drug within 28 days prior to first dose of ColoAd1

- Major surgery within 4 weeks or radiotherapy within 3 weeks prior to first dose of ColoAd1

- Another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)

- Known CNS metastasis

- Inflammatory diseases of the bowel (cohorts A and B only) or any inflammatory disease that may require treatment with corticosteroids.

- Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the drug

- Known allergy to treatment medication or its excipients

- Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Locations
Hospital Universitario Madrid Sanchinarro CIOCC
Madrid, Spain
Status: Recruiting
Contact: Emiliano Calvo, MD - emiliano.calvo@start.stoh.com
Hospital Universitario Virgen del Rocío
Seville, Spain
Status: Recruiting
Contact: Rocio G Carbonero, MD - rgcarbonero@gmail.com
Start Date
June 2013
Sponsors
PsiOxus Therapeutics Ltd
Source
PsiOxus Therapeutics Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page