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
  Purpose

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


Condition Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Immodulon Therapeutics Ltd:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 19
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided by Immodulon Therapeutics Ltd

Additional 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
Study First Received: February 16, 2011
Results First Received: March 30, 2011
Last Updated: November 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 23, 2014