Clinical trial NCT01308762: A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Immodulon Therapeutics Ltd
Sponsor class: INDUSTRY
Collaborators: name: HCA International Limited
name: Theradex
First posted: 2011-03-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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

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 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

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 56 days
Secondary outcomes:
measure: Administration Site Reactions
timeFrame: Day -3 to Day 56
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: HCA Clinical Trials Unit, 79 Harley Street,
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Justin Stebbings, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):1314-1319. doi: 10.1093/annonc/mdr363. Epub 2011 Sep 19.