A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01303172
First received: February 18, 2011
Last updated: January 28, 2014
Last verified: January 2014
  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: August 2014
Estimated Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303172

Locations
Cyprus
Cyprus Oncology Centre
Nicosia, Strovolos, Cyprus, 2006
Ireland
Adelaide, Meath & National Childrens Hospital,
Dublin, Ireland, Dublin 24
St Vicents University Hospital
Dublin, Ireland, Dublin 4
Italy
A.O. Santa Croce e Carle, Struttura Complessa di Oncologia Medica
Confreria, Cuneo, Italy
Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Azienda Ospedaliera San Gerardo Struttura Complessa Oncologia Medica
Monza, Italy, 20052
AOU Maggiore della Carità
Novara, Italy
Spain
Medical Oncology Department, Central University Hospital of Asturias
Asturias, Oviedo, Spain
Hospital General de Alicante
Alicante, Spain, 03010
Hospital Gregorio Marañon
Madrid, Spain, 28007
Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Department of Medical Oncology, Hospital Universitari La Fe,
Valencia, Spain
Hospital Miguel Servet
Zaragoza, Spain, 50009
United Kingdom
Airedale General Hospital
Skipton, West Yorkshire, United Kingdom, BD20 6TD
Royal Blackburn Hospital
Blackburn, United Kingdom, BB2 3HH
Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
Velindre Cancer Centre
Cardiff, United Kingdom, Velindre Cancer Centre
Ninewells Hospital,
Dundee, United Kingdom, DD1 9SY
The London Clinic Cancer Centre
London, United Kingdom, W1G 6BW
Mount Vernon Cancer Centre
London, United Kingdom, HA6 2RN
Peterbrough City Hospital, Haematology/Oncology Dept,
Peterborough, United Kingdom, PE3 9GZ
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: January 28, 2014
Health Authority: Italy: Ministry of Health
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board
Cyprus: Ministry of Health

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 July 24, 2014