Back to resultsA Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma
Primary Purpose
Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CB-10-01 (Transgenic Lymphocyte Immunization)
Sponsored by
About this trial
This is an interventional treatment trial for Stage IIIB Skin Melanoma focused on measuring Stage III Melanoma, Melanoma, TLI, Transgenic Lymphocyte Immunization, CB-10-01-02
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects ≥18 years of age and able to understand and give written informed consent
- Women subjects of childbearing potential (WOCBP) and male subjects must be using an effective method of contraception
Histologic diagnosis of malignant melanoma:
- Melanoma primary completely resected with negative margins. Primary surgery must be <8 weeks from leukapheresis procedure
- Stage IIIB or Stage IIIC according to the American Joint Committee on Cancer (AJCC) Tumor-Node-Metastasis (TNM) criteria (Appendix 2) OR previously resected Stage I or II melanoma that recurs as Stage IIIB or IIIC.
- HLA-A2 positive
- ECOG Performance Status of 0, 1 or 2 (Appendix 3)
Adequate bone marrow, hepatic, and renal function:
- WBC ≥1500/μL
- ANC ≥1000/μL
- Platelets ≥100 × 103/μL
- Hemoglobin ≥9 g/dL
- Creatinine ≤2 ULN
- AST ≤2 ULN
- Bilirubin ≤2 ULN (except for subjects with Gilbert's Syndrome who must have a total bilirubin <3.0 mg/mL)
- Negative screening tests for HIV, Hepatitis B and C
Exclusion Criteria:
- Female subjects, their partners and male subjects who are unwilling or unable to practice abstinence or use a barrier method (condoms) during intercourse to minimize the risk of exposure to the blood-borne transgene for the entire period of the study and for up to 8 weeks after the last TLI infusion
- Known allergy to DMSO
- Any malignancy from which the subject has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- Primary ocular or mucosal melanoma
- Autoimmune disease: subjects with a documented history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]) that has or may require systemic therapy
- Concomitant therapy with any anticancer agent; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non cancer-related illnesses). Replacement doses of corticosteroids are allowed in subjects with adrenal insufficiency
- Prior biologic therapy for melanoma
Sites / Locations
- City of Hope
- University of California Los Angeles
- University of California San Diego
- Northern California Melanoma Center
- John Wayne Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transgenic Lymphocyte Immunization
Arm Description
Open Label, Single Arm
Outcomes
Primary Outcome Measures
The primary efficacy endpoint will be the percentage of subjects who have no recurrence of metastatic melanoma at 24 months from the time of primary surgery.
Secondary Outcome Measures
Percentage of subjects who have no recurrence of metastatic melanoma 9 and 16 months following the time of primary surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00925314
Brief Title
A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma
Official Title
A Phase 2, Open-Label Evaluation of the Safety and Efficacy of CB-10-01, Transgenic Lymphocyte Immunization (TLI) Against Telomerase, as Adjuvant Therapy in Subjects With Stage III Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cosmo Bioscience
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety, efficacy, and immunological response to the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma.
Normal cells in the body have an established lifespan. Cancer cells on the other hand have the ability to continue to divide into new cells indefinitely. More than 85% of cancer has this ability because of an enzyme found in the cancer cell. The Investigational Product, Transgenic Lymphocyte Immunization (TLI), is aimed at helping the immune system target this enzyme found in most cancerous cells.
Subjects who meet all inclusion and exclusion criteria will undergo a leukapheresis in which white blood cells will be collected and used to manufacture their own personal study product. Subjects will receive 3 infusions of TLI roughly 1 month apart and will be followed over a 2 year period with routine laboratory draws, computed tomography (CT) scans and physical exams.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
Keywords
Stage III Melanoma, Melanoma, TLI, Transgenic Lymphocyte Immunization, CB-10-01-02
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transgenic Lymphocyte Immunization
Arm Type
Experimental
Arm Description
Open Label, Single Arm
Intervention Type
Biological
Intervention Name(s)
CB-10-01 (Transgenic Lymphocyte Immunization)
Other Intervention Name(s)
TLI
Intervention Description
1 Primary Infusion and 2 Booster Infusions
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will be the percentage of subjects who have no recurrence of metastatic melanoma at 24 months from the time of primary surgery.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Percentage of subjects who have no recurrence of metastatic melanoma 9 and 16 months following the time of primary surgery.
Time Frame
9 and 16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects ≥18 years of age and able to understand and give written informed consent
Women subjects of childbearing potential (WOCBP) and male subjects must be using an effective method of contraception
Histologic diagnosis of malignant melanoma:
Melanoma primary completely resected with negative margins. Primary surgery must be <8 weeks from leukapheresis procedure
Stage IIIB or Stage IIIC according to the American Joint Committee on Cancer (AJCC) Tumor-Node-Metastasis (TNM) criteria (Appendix 2) OR previously resected Stage I or II melanoma that recurs as Stage IIIB or IIIC.
HLA-A2 positive
ECOG Performance Status of 0, 1 or 2 (Appendix 3)
Adequate bone marrow, hepatic, and renal function:
WBC ≥1500/μL
ANC ≥1000/μL
Platelets ≥100 × 103/μL
Hemoglobin ≥9 g/dL
Creatinine ≤2 ULN
AST ≤2 ULN
Bilirubin ≤2 ULN (except for subjects with Gilbert's Syndrome who must have a total bilirubin <3.0 mg/mL)
Negative screening tests for HIV, Hepatitis B and C
Exclusion Criteria:
Female subjects, their partners and male subjects who are unwilling or unable to practice abstinence or use a barrier method (condoms) during intercourse to minimize the risk of exposure to the blood-borne transgene for the entire period of the study and for up to 8 weeks after the last TLI infusion
Known allergy to DMSO
Any malignancy from which the subject has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
Primary ocular or mucosal melanoma
Autoimmune disease: subjects with a documented history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]) that has or may require systemic therapy
Concomitant therapy with any anticancer agent; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non cancer-related illnesses). Replacement doses of corticosteroids are allowed in subjects with adrenal insufficiency
Prior biologic therapy for melanoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Daniels, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Northern California Melanoma Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma
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