A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients - Full Text View

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:

MedlinePlus related topics: Melanoma

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

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

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 (Adult, Senior)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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):1314-9. doi: 10.1093/annonc/mdr363. Epub 2011 Sep 19.


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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas

ClinicalTrials.gov processed this record on September 23, 2016