The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma

NCT03928275 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 14549
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators aim to include 100 local participants over the next 5 years in a two-stage sequential randomized interventional study of intralesional Interleukin-2 (IL-2) and Bacillus Calmette Guerin (BCG) to assess the utility of treating cutaneous metastatic melanoma (CMM).

Conditions

Cutaneous Metastatic Melanoma

Keywords

Interleukin-2; Bacillus Calmette Guerin

Outcome Measures

Primary Outcomes (1)

• Number of CMM participants that respond to IL-2 compared to the number of participants that respond to IL-2 and BCG.

  The primary outcome measure is the achievement of a superior response rate in patients receiving combination IL-2/BCG treatment compared to patients receiving IL-2 alone. Patient response to treatment will be monitored and patients will be categorized as 1) complete responders, 2) partial responders or 3) stable disease. Data will be analyzed by one-way ANOVA to compare proportion outcomes amongst treatment and response groups.

  5 years

Secondary Outcomes (5)

• Number of patients that respond to the addition of BCG in stage two compared to the number of patients respond to continued IL-2 treatment.

  5 years

• Assessment of overall survival in stage one treatment

  5 years

• Assessment of overall survival in stage two treatment

  5 years

• Assessment of Disease Progression Within Stage of Disease: Number of stable and/or new metastasis

  5 years

• Assessment of Metastasis

  5 years

Study Arms (2)

Intralesional IL-2 Treatment

EXPERIMENTAL

CMM patients will received 4 treatments of intralesional Interleukin-2 two weeks apart over an eight week period.

Biological: Interleukin-2

Combination therapy: Intralesional IL-2 and BCG Treatment

EXPERIMENTAL

CMM patients will receive 4 treatments of combination therapy intralesional Interleukin-2 and Bacillus Calmette Guerin two weeks apart over an eight week period.

Biological: Combination therapy Interleukin-2 and Bacillus Calmette Guerin

Interventions

Interleukin-2 BIOLOGICAL

IL-2 is prepared as 4 million International Units (IU) per 0.8ml at a total dose of 500,000 IU in 0.1ml of sterilized saline (0.9%, m/v)/lesion.

Also known as: Proleukin (Aldesleukin)

Intralesional IL-2 Treatment

Combination therapy Interleukin-2 and Bacillus Calmette Guerin BIOLOGICAL

BCG (OncoTICE solutions 1-8 x 10-8 Colony Forming Units (CFU)) will be administered at a maximum dose of 3.2 million CFU per treatment at a maximum of 1.6 million CFU per lesion (max 2 lesions). IL-2 is prepared as 4 million International Units (IU) per 0.8ml at a total dose of 500,000 IU in 0.1ml of sterilized saline (0.9%, m/v)/lesion (in remaining lesions).

Also known as: BCG, strain TICE (OncoTICE) and Proleukin (Aldesleukin)

Combination therapy: Intralesional IL-2 and BCG Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with cutaneous metastatic melanoma.
• Has 4 or more melanoma lesions.
• Between18 and 80 years of age.

You may not qualify if:

• Immunocompromized.
• Receiving immuno-therapy for other diagnosis.
• Inflammatory disease.
• Autoimmune disease.
• Pregnant
• HIV
• Test positive for TB

Sponsors & Collaborators

• Carman Giacomantonio: lead
• Nova Scotia Health Authority: collaborator

MeSH Terms

Interventions

Interleukin-2; aldesleukin; BCG Vaccine

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Carman A Giacomantonio, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgical Oncologist/General Surgeon/Professor

Model Details: Patients will be randomized to first stage treatment and allocated to 1) IL-2 or 2) IL-2/BCG treatment. First stage treatment patients receive 4 treatments of 1) IL-2 or 2) IL-2 and BCG. Patient response will be determined for treatment groups following iRECIST guidelines as; 1) complete responder, 2) partial responder, or 3) stable disease. In second stage treatment, patients who completely respond to first stage treatment will be randomized to 1) discontinue treatment and followed every 3 mos for 2 yrs and then every 6 mos from yrs 3-5, or 2) will receive 2 additional treatments and then followed every 3 mos for 2 yrs and then every 6 mos from yrs 3-5. Patients that do not completely respond to first stage treatment, will be re-staged using a PET/CT scan. Patients not requiring escalation to systemic therapy will be randomized and advance to second stage treatment (IL-2, IL-2 and BCG, or BCG).

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 26, 2019
• Study Start: December 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share