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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Cosmo Bioscience.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Cosmo Bioscience
ClinicalTrials.gov Identifier:
NCT00925314
First received: June 18, 2009
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Biological: CB-10-01 (Transgenic Lymphocyte Immunization)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cosmo Bioscience:

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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2007
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925314

Locations
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
Investigators
Principal Investigator: Gregory Daniels, MD, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: Cosmo Bioscience
ClinicalTrials.gov Identifier: NCT00925314     History of Changes
Other Study ID Numbers: CB-10-01-02
Study First Received: June 18, 2009
Last Updated: February 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cosmo Bioscience:
Stage III Melanoma
Melanoma
TLI
Transgenic Lymphocyte Immunization
CB-10-01-02

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014