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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308762
• Other study ID #: IMM-101-001
• Secondary ID: 2009-012447-42
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2011
• Last updated: November 8, 2012
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2012
• Source: Immodulon Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Melanoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	HCA Clinical Trials Unit, 79 Harley Street,	London

Sponsors (3)

Lead Sponsor	Collaborator
Immodulon Therapeutics Ltd	HCA International Limited, Theradex

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Safety and tolerability were measured with respect to: Safety measurements; Local tolerability at the site of intradermal injection; Incidence of adverse events.	56 days	Yes
Secondary	Administration Site Reactions	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.	Day -3 to Day 56	Yes