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

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Status and phase

Unknown

Phase 2

Conditions

Stage IIIC Skin Melanoma

Stage IIIB Skin Melanoma

Treatments

Biological: CB-10-01 (Transgenic Lymphocyte Immunization)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00925314

CB-10-01-02

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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