Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Trial of Immunotherapy With Adenovirus-Interferon- Gamma (TG1041) in Patients With Malignant Melanoma
RATIONALE: Interferon gamma may interfere with the growth of cancer cells and may be an
effective treatment for melanoma and solid tumors.
PURPOSE: Phase I trial to study the effectiveness of interferon gamma in treating patients
with recurrent or metastatic melanoma or other solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose of intratumoral adenovirus vector
containing interferon gamma in patients with locally recurrent or metastatic melanoma or
other solid tumors. II. Assess the safety and tolerability of this regimen in this patient
population. III. Determine the local or distant antitumor effect of this regimen in these
patients. IV. Evaluate the biological and immunological effects of this regimen and the
extent of local interferon gamma expression in these patients.
OUTLINE: This is a dose escalation study. Patients receive adenovirus interferon gamma
intratumorally on days 1, 8, and 15. Patients achieving tumoral response may receive
additional courses of therapy at the discretion of the investigator. Cohorts of at least 3
patients receive escalating doses of adenovirus interferon gamma until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6
patients experience dose limiting toxicity. Patients are followed for 3 weeks after
treatment.
PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study.
;
Primary Purpose: Treatment
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