a study of t-vec (talimogene laherparepvec) with or without radiotherapy for melanoma, merkel cell carcinoma, or other solid tumors

Conditions: Melanoma; Merkel Cell Carcinoma; Other Solid Tumors

Summary: the purpose of this phase ii clinical study is to test the good and bad effects of t-vec (talimogene laherparepvec) with or without hypofractionated radiotherapy on people with melanoma, merkel cell carcinoma, or other solid tumors with skin metastasis.


Eligibility criteria:
inclusion criteria: * man or woman ≥ 18 years old * life expectancy \> 4 months * histopathologically confirmed melanoma, merkel cell carcinoma or other solid tumor malignancy * cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis not suitable for surgical resection * eastern cooperative oncology group (ecog) performance status 0 to 2 * cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to injection and irradiation and \> 10 mm in longest dimension ° cutaneous metastasis in a region of previous radiation therapy is amenable to radiation therapy as part of this protocol if at least 6 months has elapsed since prior radiotherapy and the dose of radiotherapy previously administered did not exceed an equivalent dose of 60 gy in 2 gy equivalent fractions at the skin surface (using linear-quadratic modeling with alpha/beta=11.5) * metastasis that is \> 10 mm in longest dimensionor exhibits radiotracer uptake consistent with metastasis on pet/ct * adequate coagulation function (platelet count \>50 k/mcl, international normalized ratio of \< 1.5) * resolution or stabilization of clinically significant adverse events from prior therapy * able to provide valid written informed consent exclusion criteria: * active herpetic skin lesions or prior complications of hsv-1 infection (such as herpetic keratitis, herpetic encephalitis) * receipt of a therapeutic anticoagulant * receipt of live vaccine within 28 days of planned first dose of tvec * receipt of another cancer therapy (targeted therapy, chemotherapy, investigational therapy, immunotherapy, radiotherapy or surgery) which is yielding an overall response (by response criteria in this study) ° patients with stable or progressing disease (as determined by at least 2 consecutive assessments at 6-week interval) can continue to receive the same therapy during treatment as part of this protocol * history of symptomatic autoimmune disease (such as lupus, scleroderma, crohn's disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatment * history of high grade (ctcae ≥ grade 3) immune mediated adverse event from prior cancer immunotherapy * history of ctcae ≥ grade 2 immune mediated endocrinopathy from prior cancer immunotherapy * intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir) * active or chronic hepatitis b or c infection ° previously infected, with evidence of immunity and no evidence of active hepatitis is not an exclusion criterion * known human immunodeficiency virus (hiv) infection * known leukemia or lymphoma * common variable immunodeficiency * patients requiring chronic high dose immunosuppressants including steroids (prednisone daily equivalent of ≥ 10 mg) * known severe congenital or acquired cellular or humoral immunodeficient or immunocompromised patients * high likelihood of protocol non-compliance (in opinion of investigator) * woman of childbearing potential unwilling to use effective contraception during protocol treatment and for 3 months after last dose of talimogene laherparepvec * woman of childbearing potential that is pregnant or breast-feeding, or planning to become pregnant or breast-feed during protocol treatment and for 3 months after last dose of talimogene laherparepvec

Keywords: t-vec (talimogene laherparepvec) radiotherapy 16-224