A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00925314
Recruitment Status : Unknown
Verified February 2012 by Cosmo Bioscience.
Recruitment status was:  Active, not recruiting
First Posted : June 22, 2009
Last Update Posted : February 13, 2012
Information provided by (Responsible Party):
Cosmo Bioscience

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.

Condition or disease Intervention/treatment Phase
Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Biological: CB-10-01 (Transgenic Lymphocyte Immunization) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2007
Actual Primary Completion Date : July 2011
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transgenic Lymphocyte Immunization
Open Label, Single Arm
Biological: CB-10-01 (Transgenic Lymphocyte Immunization)
1 Primary Infusion and 2 Booster Infusions
Other Name: TLI

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00925314

United States, California
City of Hope
Duarte, California, United States, 91010
University of California Los Angeles
Los Angeles, California, United States, 90024
University of California San Diego
San Diego, California, United States, 92093
Northern California Melanoma Center
San Francisco, California, United States, 94117
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Cosmo Bioscience
Principal Investigator: Gregory Daniels, MD, PhD University of California, San Diego

Responsible Party: Cosmo Bioscience Identifier: NCT00925314     History of Changes
Other Study ID Numbers: CB-10-01-02
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by Cosmo Bioscience:
Stage III Melanoma
Transgenic Lymphocyte Immunization

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs