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

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ClinicalTrials.gov Identifier: NCT01308762
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Collaborators:
HCA International Limited
Theradex
Information provided by (Responsible Party):
Immodulon Therapeutics Ltd

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

Condition or disease Intervention/treatment Phase
Melanoma 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 Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: 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
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
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'

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



Primary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 56 days ]

    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.


Secondary Outcome Measures :
  1. Administration Site Reactions [ Time Frame: Day -3 to Day 56 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308762


Locations
United Kingdom
HCA Clinical Trials Unit, 79 Harley Street,
London, United Kingdom, W1G 8PZ
Sponsors and Collaborators
Immodulon Therapeutics Ltd
HCA International Limited
Theradex
Investigators
Principal Investigator: Justin Stebbings, Professor Imperial College Healthcare NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT01308762     History of Changes
Other Study ID Numbers: IMM-101-001
2009-012447-42 ( EudraCT Number )
First Posted: March 4, 2011    Key Record Dates
Results First Posted: December 6, 2012
Last Update Posted: December 6, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas