A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
NCT ID: NCT01308762
Last Updated: 2012-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2010-03-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SINGLE
Study Groups
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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'
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* willing to use effective contraception for the duration of the study
* able to comply with the requirement to complete a diary card
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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HCA International Limited
OTHER
Theradex
INDUSTRY
Immodulon Therapeutics Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Justin Stebbings, Professor
Role: PRINCIPAL_INVESTIGATOR
Imperial College Healthcare NHS Trust
Locations
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HCA Clinical Trials Unit, 79 Harley Street,
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2009-012447-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMM-101-001
Identifier Type: -
Identifier Source: org_study_id