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
18 Years
N/A
Both
Melanoma
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Outcome Measure:
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Outcome Description:
Safety and tolerability were measured with respect to: Safety measurements Local tolerability at the site of intradermal injection Incidence of adverse events.
Outcome Time Frame:
56 days
Safety Issue:
Yes
Principal Investigator
Justin Stebbings, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Imperial College Healthcare NHS Trust
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
IMM-101-001
NCT ID:
NCT01308762
Start Date:
March 2010
Completion Date:
September 2010
Related Keywords:
- Melanoma
- Melanoma
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