A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
This study is currently recruiting participants.
Verified March 2013 by Immodulon Therapeutics Ltd
Sponsor:
Immodulon Therapeutics Ltd
Information provided by (Responsible Party):
Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01303172
First received: February 18, 2011
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected markers of tumour burden and immunological status, and disease outcome.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Biological: IMM-101 Drug: Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by Immodulon Therapeutics Ltd:
Primary Outcome Measures:
- No clinically relevant deleterious effect of IMM-101 on safety and tolerability. [ Time Frame: After 12 months or as clinically indicated ] [ Designated as safety issue: Yes ]
A clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles will be judged by:
- Local and systemic toxicities.
- Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
- QoL (EORTC QLQ-C30 questionnaire supplemented by the pancreas cancer specific EORTC QLQ-PAN26 questionnaire).Efficacy will be defined as a clinically relevant improvement in one or more markers of disease status.
Secondary Outcome Measures:
- A clinically relevant improvement in one or more markers of disease status [ Time Frame: 12 months or as clinically indicated ] [ Designated as safety issue: No ]
A clinically relevant improvement in one or more markers of disease status:
- Overall survival (OS).
- Progression-free survival (PFS).
- Overall response rate (ORR).
- Reduction in metastatic disease.
- Circulating levels of carbohydrate antigen 19.9 (CA19.9).
- Circulating levels of carcinoembryonic antigen (CEA).
- Nutritional status (weight, appetite, serum albumin).
- Pain control and analgesic use.
- Immunological markers [ Time Frame: 12 months or as clinically indicated ] [ Designated as safety issue: No ]
Blood samples will be collected from all patients for analysis of immunological markers and mediators (e.g. cytokines and antibodies, any other immunologically relevant assays.
For a subset of patients cells will be isolated from the whole blood samples. Exploratory endpoints may include:
- A change in levels of circulating tumour cells (CTCs)
- A change in one or more markers of immune status
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: gemcitabine chemotherapy
Patients in the control arm will receive normal standard of care - up to 12 cycles of Gemcitabine. Dosing of Gemcitabine is as per the normal orescribing information for pancreatic cancer.
|
Drug: Gemcitabine
Gemcitabine will be administered intravenously at 1000 mg/m2 over 30 minutes once weekly for 3 consecutive weeks out of every 4 weeks. Chemotherapy will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks). Dosage reduction with each cycle or within each cycle may be applied based upon the grade of Gemcitabine-related toxicity experienced by the patient using centre's standard protocol. Other Name: Gemzar
|
|
Experimental: IMM-101 in addition to gemcitabine
Patients in the experiemental arm will recieve IMM-101 in addition the current standard of care, namely chemotherapy (Gemcitabine). The treatment regimen with IMM-101 will be every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter. For patients in the active group, chemotherapy (GEM) will begin at least 14 days after first dose of IMM-101. Chemotherapy plus IMM-101 will be offered until intolerable toxcity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks). |
Biological: IMM-101
IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline. A single 0.1 mL intradermal injection of IMM-101 (10 mg/mL)will be administered every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter. Chemotherapy plus IMM-101 will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles of gemcitabine. Other Name: Heat killed whole cell Mycobacterium obuense, M. obuense
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically and/or cytologically confirmed inoperable ductal adenocarcinoma of the pancreas, including the mucinous variant. This will include locally advanced and metastatic disease (stage III/IV).
- Presence of measurable lesions in at least one site which have not been previously irradiated (bone lesions, ascites and pleural effusions are not considered as measurable), described as any of the following:
- WHO performance status of 0-2
- serum creatinine <140 μmol/L
- white blood cell (WBC) count, including differential counts within the normal range
- a life expectancy of >3 months from randomisation
Exclusion Criteria:
- acinar cell carcinoma, neuroendocrine tumours, lymphomas or squamous cell carcinomas.
- severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments.
- any previous chemotherapy treatment for pancreatic cancer.
- eligible for resection of the pancreatic primary tumour but has either refused the operation or is considered to be medically unfit for the operation.
- clinical or CT evidence of central nervous system (CNS) metastases.
- any previous treatment with IMM-101 or related mycobacterial immunotherapy.
- serum albumin < 26 g/L.
- C-reactive protein (CRP) > 70 mg/L.
- radiotherapy in the 6 weeks prior to screening.
- depot corticosteroids in the 6 weeks prior to screening.
- chronic use of any systemic corticosteroids and/or immunosuppressant drugs within the 2-week period prior to the first administration of study drug
- female patient of child-bearing potential who is not, in the opinion of the Investigator, using an approved method of birth control (
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303172
Contacts
| Contact: Angus Dalgleish, Professor | +44 (0) 20 8725 0809 | dalgleis@sgul.ac.uk |
| Contact: Hilary Bilyard, Dr. | +44 (0)203 219 3568 | info@immodulon.com |
Locations
| Cyprus | |
| Cyprus Oncology Centre | Recruiting |
| Nicosia, Strovolos, Cyprus, 2006 | |
| Contact: Demitris Papamichael 0035 7228413006 emetris.papamichael@bococ.org.cy | |
| Principal Investigator: Demitris Papamichael | |
| Ireland | |
| Adelaide, Meath & National Childrens Hospital, | Recruiting |
| Dublin, Ireland, Dublin 24 | |
| Contact: Ray McDermott | |
| Principal Investigator: Ray McDermott | |
| St Vicents University Hospital | Recruiting |
| Dublin, Ireland, Dublin 4 | |
| Contact: Ray McDermott | |
| Principal Investigator: Ray McDermott | |
| Italy | |
| A.O. Santa Croce e Carle, Struttura Complessa di Oncologia Medica | Recruiting |
| Confreria, Cuneo, Italy | |
| Contact: Granetto, Dr : +39 0171 616738 trials@ospedale.cuneo.it | |
| Principal Investigator: Granetto, Dr | |
| Azienda Ospedaliero-Universitaria di Bologna | Completed |
| Bologna, Italy, 40138 | |
| Fondazione Poliambulanza | Withdrawn |
| Brescia, Italy, 25124 | |
| Azienda Ospedaliera San Gerardo Struttura Complessa Oncologia Medica | Recruiting |
| Monza, Italy, 20052 | |
| Contact: Bidoli +39 039 23395754 p.bidoli@hsgerardo.org | |
| Principal Investigator: Paolo Bidoli | |
| AOU Maggiore della Carità | Recruiting |
| Novara, Italy | |
| Contact: OSCAR ALABISO +3903213733068 poloncno@maggioreosp.novara.it | |
| Principal Investigator: OSCAR ALABISO | |
| Spain | |
| Medical Oncology Department, Central University Hospital of Asturias | Recruiting |
| Asturias, Oviedo, Spain | |
| Contact: José María Vieitez de Prado +34 985 108 000 | |
| Principal Investigator: Jose Maria Vietitez De Prado, Dr. | |
| Hospital General de Alicante | Recruiting |
| Alicante, Spain, 03010 | |
| Contact: Bartomeu Massutti, Dr. + 34699439910 massuti_bar@gva.es | |
| Contact + 34965259654 | |
| Principal Investigator: Bartomeu Massutti, Dr. | |
| Hospital Gregorio Marañon | Recruiting |
| Madrid, Spain, 28007 | |
| Contact: Andres Muñoz, Dr +34 91 426 90 70 coordinacion@sincivo.org | |
| Contact cfmartos@fivo.org | |
| Principal Investigator: Andres Munoz, Dr | |
| Instituto Valenciano de Oncologia | Recruiting |
| Valencia, Spain, 46009 | |
| Contact: Carlos Fernandez - Martos +34 961114013 cfmartos@fivo.org | |
| Contact coordinacion@sincivo.org | |
| Principal Investigator: Carlos Fernandez-Martos | |
| Department of Medical Oncology, Hospital Universitari La Fe, | Recruiting |
| Valencia, Spain | |
| Contact: Roberto Pedro Diaz Beveridge, Dr. :+34 961 24 40 00 | |
| Principal Investigator: Roberto Pedro Diaz Beveridge, Dr. | |
| Hospital Miguel Servet | Recruiting |
| Zaragoza, Spain, 50009 | |
| Contact: Roberto Pazo +34 976 359 268 ext 3825 aantont@gmail.com | |
| Principal Investigator: Roberto Pazo | |
| United Kingdom | |
| Airedale General Hospital | Recruiting |
| Skipton, West Yorkshire, United Kingdom, BD20 6TD | |
| Contact 01535 292839 sue.cheeseman@bradfordhospitals.nhs.uk | |
| Principal Investigator: Sue Cheeseman, Dr. | |
| Royal Blackburn Hospital | Recruiting |
| Blackburn, United Kingdom, BB2 3HH | |
| Contact: Ajay Mehta, Dr + 44(0)1254 734 019 Ajay.Mehta@lthtr.nhs.uk | |
| Principal Investigator: Ajay Mehta, Dr | |
| Bradford Royal Infirmary | Recruiting |
| Bradford, United Kingdom, BD9 6RJ | |
| Contact: Sue Cheeseman 01274 382455 sue.cheeseman@bradfordhospitals.nhs.uk | |
| Principal Investigator: Sue Cheeseman | |
| Velindre Cancer Centre | Recruiting |
| Cardiff, United Kingdom, Velindre Cancer Centre | |
| Contact: Seema Arif 029 2019 6184 SEEMA.ARIF@WALES.NHS.UK | |
| Principal Investigator: Seema Arif | |
| Ninewells Hospital, | Recruiting |
| Dundee, United Kingdom, DD1 9SY | |
| Contact: Douglas Adamson, Dr 01382 660111 | |
| Principal Investigator: Douglas Adamson | |
| The London Clinic Cancer Centre | Completed |
| London, United Kingdom, W1G 6BW | |
| Mount Vernon Cancer Centre | Recruiting |
| London, United Kingdom, HA6 2RN | |
| Contact: Rob Glynne-Jones 01923 844767 rob.glynnejones@nhs.net | |
| Principal Investigator: Rob Glynne-Jones | |
| Peterbrough City Hospital, Haematology/Oncology Dept, | Recruiting |
| Peterborough, United Kingdom, PE3 9GZ | |
| Contact: Karen McAdam, Dr 01733 673188 karen.mcadam@pbh-tr.nhs.uk | |
| Principal Investigator: Karen McAdam, Dr. | |
Sponsors and Collaborators
Immodulon Therapeutics Ltd
Investigators
| Principal Investigator: | Angus Dalgleish, Professor | St George's, University of London |
More Information
No publications provided
| Responsible Party: | Immodulon Therapeutics Ltd |
| ClinicalTrials.gov Identifier: | NCT01303172 History of Changes |
| Other Study ID Numbers: | IMM-101-002 |
| Study First Received: | February 18, 2011 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Italy: Ministry of Health Spain: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013