A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
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
2 other identifiers
interventional
19
1 country
1
Brief Summary
To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedResults Posted
Study results publicly available
December 6, 2012
CompletedDecember 6, 2012
September 1, 2012
6 months
February 16, 2011
March 30, 2011
November 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
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.
56 days
Secondary Outcomes (1)
Administration Site Reactions
Day -3 to Day 56
Study Arms (1)
IMM-101
EXPERIMENTALPatients 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'
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Immodulon Therapeutics Ltdlead
- HCA International Limitedcollaborator
- Theradexcollaborator
Study Sites (1)
HCA Clinical Trials Unit, 79 Harley Street,
London, W1G 8PZ, United Kingdom
Related Publications (1)
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.
PMID: 21930686DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Co-ordinator
- Organization
- Immodulon Therapeutics, The London Clinic Cancer Centre, London W1G 6JA,
Study Officials
- PRINCIPAL INVESTIGATOR
Justin Stebbings, Professor
Imperial College Healthcare NHS Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2011
First Posted
March 4, 2011
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
December 6, 2012
Results First Posted
December 6, 2012
Record last verified: 2012-09