A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
HCA International Limited
Theradex
Information provided by (Responsible Party):
Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01308762
First received: February 16, 2011
Last updated: November 8, 2012
Last verified: September 2012

February 16, 2011
November 8, 2012
March 2010
September 2010   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Safety and tolerability were measured with respect to:

  1. Safety measurements
  2. Local tolerability at the site of intradermal injection
  3. Incidence of adverse events.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
Outcome measures will include safety measurements, clinically significant changes in safety measurements, and the incidence and nature of adverse events.
Complete list of historical versions of study NCT01308762 on ClinicalTrials.gov Archive Site
Administration Site Reactions [ Time Frame: Day -3 to Day 56 ] [ Designated as safety issue: Yes ]
Local skin reactions are viewed as a normal and predicted reaction to exposure to a preparation of mycobacterial antigens. All patients experienced administration site reactions and all reactions were examined and characterised. However only those reported as adverse events are presented here.
Administration site reactions [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Assessment of local tolerability at the site of intradermal injection. The study aims to characterise local responses to IMM 101 using standardised nomenclature and toxicology criteria. The methods employed in this study may help to delineate inappropriate/unacceptable local reactions from those indicative of a beneficial immunological response in future studies of IMM-101 in cancer patients.
Not Provided
Not Provided
 
A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
An Intra-patient Placebo-controlled, Phase I Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 (Heat-killed Mycobacterium Obuense) in Adult Melanoma Cancer Patients

To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.

The proposed study is a first-in-man, placebo-controlled, dose escalation trial to evaluate the safety and tolerability of three different doses of IMM-101 administered intradermally to melanoma patients. Additionally, the study aims to characterize local responses to this vaccine in order to delineate unexpected / unacceptable local reactions from those indicative of appropriate immunological response in this patient group.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Melanoma
  • Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg

    Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.

    Dose levels to be administered are 0.1 mg, 0.5 mg and 1.0 mg.

    Other Names:
    • IMM-101
    • Mycobaterium obuense
  • Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg
    Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
    Other Names:
    • IMM-101
    • Mycobaterium obuense
  • Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg
    Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
    Other Names:
    • IMM-101
    • Mycobaterium obuense
Experimental: IMM-101

Patients received an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28. Doses used were:

'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'

Interventions:
  • Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg
  • Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg
  • Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg
Stebbing J, Dalgleish A, Gifford-Moore A, Martin A, Gleeson C, Wilson G, Brunet LR, Grange J, Mudan S. An intra-patient placebo-controlled phase I trial to evaluate the safety and tolerability of intradermal IMM-101 in melanoma. Ann Oncol. 2012 May;23(5):1314-9. doi: 10.1093/annonc/mdr363. Epub 2011 Sep 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • confirmed diagnosis of disease free stage III or stage IV melanoma (with or without metastases) or stable disease (if with metastases) and receiving no other treatment
  • willing to use effective contraception for the duration of the study
  • able to comply with the requirement to complete a diary card

Exclusion Criteria:

  • Pregnant or lactating females
  • Major surgery within the 14 days preceding the screening visit
  • Suspicion of a previous infection with mycobacteria including previous tuberculosis (TB) prophylaxis
  • Treatment with another investigational medicinal product within the last 30 days prior to the screening visit
  • Previous treatment with M. vaccae
  • Exposure to Bacille Calmette Guérin vaccine (BCG) within the last 12 months
  • Concurrent uses of drugs likely to reduce inflammation at the local injection site or dampen/modulate the immune system
  • Depot injection of corticosteroids within 6 weeks of the screening visit or chronic systemic corticosteroids in the 2 weeks prior to the screening visit
  • Ongoing treatment with radiotherapy, cytotoxic chemotherapy or chemotherapy in the last 30 days prior to the screening visit
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01308762
IMM-101-001, 2009-012447-42
No
Immodulon Therapeutics Ltd
Immodulon Therapeutics Ltd
  • HCA International Limited
  • Theradex
Principal Investigator: Justin Stebbings, Professor Imperial College Healthcare NHS Trust
Immodulon Therapeutics Ltd
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP