A Phase 1 Multi-center Open-label Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non-Central Nervous System Tumors That are Amenable to Direct Injection

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Non-Central Nervous System Tumor | advanced non central nervous system tumors
  • Age: Between 2 - 21 Years
  • Gender: Male or Female

Inclusion Criteria
Subject's legally acceptable representative has provided informed consent/assent when the subject is legally too young to provide informed consent/assent and the subject has provided written assent based on local regulations and/or guidelines prior to any study specific activities/procedures being initiated
Willing to submit local HSV-1 serostatus within 28 days prior to enrollment
Histologically or cytologically confirmed non-CNS solid tumor that recurred after standard therapy or for which there is no standard therapy available
Presence of measurable or nonmeasurable disease
Subject must be a candidate for intralesional injection, defined as one or more of the following
At least 1 injectable lesion ? 10 mm in longest diameter
Multiple injectable lesions that in aggregate have a longest diameter of ? 10 mm
Performance status as outlined in protocol
Life expectancy > 4 months from the date of enrollment
Exclusion Criteria
Diagnosis of leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, or other hematologic malignancy
Radiotherapy to the bone marrow within 6 weeks prior to enrollment OR within 3 months prior to enrollment if prior radiotherapy to the craniospinal axis or to at least 60% of the pelvis was received
Within 2 weeks prior to enrollment if local palliative radiotherapy was received
CNS tumor or clinically active brain metastases
Primary ocular or mucosal melanoma
History or evidence of giant congenital melanocytic nevi, dysplastic nevis syndrome or xeroderma pigmentosum
History of other malignancy within the past 5 years with exception(s) outlined in protocol, History or evidence of active autoimmune disease that requires systemic treatment, replacement therapy is not considered a form of systemic treatment
Evidence of clinically significant immunosuppression as outlined in protocol
Active herpetic skin lesions or prior complications of herpetic infection

Recruitment Status

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If you need help finding a study or have any questions, please contact us at inhealth@iu.edu or by phone at (888) 264-0005.