Phase I/II clinical trial of biologic therapy with intratumoral TG1042 (Adenovirus-Interferon-gamma) in patients with Advanced Cutaneous T-Cell Lymphomas (CTCL) - Mycosis Fungoides and other CTCL - and multilesional Cutaneous B-Cell Lymphomas (CBCL)

Transgene0 sites39 target enrollmentStarted: November 25, 2009Last updated: August 19, 2024

Conditions

Trial Snapshot

No summary available.

•Patient must satisfy all of the following criteria for entry into the protocol:
•- histologic proof of CTCL (mycosis fungoides and other CTCL except for Sezary Syndrom and Lymphomatoid papulosis for the 5th cohort only) or multilesional CBCL
•- performance status of 0, 1, or 2 on the ECOG scale
•- TNM stage Ib or higher
•- failure of local tumor control by at least two first line treatments ( local steroids, PUVA, retinoids, Interferon-alpha, BCNU, radiotherapy, and antibiotics in CBCL)
•- Prior treatment for diagnosis: no systemic chemotherapy or immunotherapy for metastatic or locally recurrent disease within preceeding three weeks
•- minimum life expectancy >3 months
•- adequate hematologic, hepatic and renal function
•- hemoglobin >=10.0g/dl; WBC>=3.0 x 10e9/l; Platelet Count >=100 x 10e9/l
•- Bilirubin <=2 times the upper limit of normal and serum transaminase <= 3 times the upper limit of normal
•- Creatinine <= 2 times the upper limit of normal
•- serum Prothrombin < 1 second greater than the upper limit of normal
•- Age >= 18 years old
•- Written informed consent from patients

•Patients will be excluded from the study for any of the following reasons:
•- history of known HIV positive serology or other active systemic infections
•- serious, concomitant systemic medical disorders
•- Concomitant systemic and topical corticosteroid therapy
•- Participation in another experimental treatment protocol during the study period
•- Major surgery in previous 3 weeks
•- require or likely to require corticosteroids for intercurrent disease
•- pregnancy at the entry or women who are breast feeding
•- Patients without adequate protection against pregnancy during the conduct of the study and for three months after the last injection (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide)
•- Participation in another experimental protocol during the study within 4 weeks prior to the first examinations required by the protocol of this study
•- history of substance abuse

Sponsor