Status:
UNKNOWN
A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma
Lead Sponsor:
Cosmo Bioscience
Conditions:
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00925314
Start Date
June 1 2007
End Date
July 1 2014
Last Update
February 13 2012
Active Locations (5)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California Los Angeles
Los Angeles, California, United States, 90024
3
University of California San Diego
San Diego, California, United States, 92093
4
Northern California Melanoma Center
San Francisco, California, United States, 94117