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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	19 participants
Intervention Model:	Single Group Assignment
Masking:	Single (Participant)
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 Start Date :	March 2010
Actual Primary Completion Date :	September 2010
Actual Study Completion Date :	September 2010

Arms and Interventions

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Arm

Intervention/treatment

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

Outcome Measures

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Primary Outcome Measures :

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 56 days ]

   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 :

1. Administration Site Reactions [ Time Frame: Day -3 to Day 56 ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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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 ( EudraCT Number )
First Posted:	March 4, 2011
Results First Posted:	December 6, 2012
Last Update Posted:	December 6, 2012
Last Verified:	September 2012

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