Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Trial Parameters
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Brief Summary
This phase I trial tests the safety, side effects, and best dose of combination therapy with liposomal doxorubicin and peposertib in treating patients with sarcoma that has spread from where it first started, to other places in the body (metastatic), or cannot be removed by surgery (unresectable) and for which no known cure is available (advanced). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also enhance the activity of chemo- and radiotherapy. There is some pre-clinical evidence in animal models that combining peposertib with liposomal doxorubicin can shrink or stabilize certain types of cancer for longer than either drug alone, but it is not known if this will happen in people. Combination therapy with liposomal doxorubicin and peposertib may be effective in treating patients with advanced sarcoma.
Eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed sarcoma that is metastatic or unresectable and for which there is no known curative treatment * Dose escalation cohort: Patients must have histologic diagnosis of leiomyosarcoma (LMS) or selected soft tissue sarcomas (myxofibrosarcoma \[MFS\], undifferentiated pleomorphic sarcoma \[UPS\], synovial sarcoma, or dedifferentiated liposarcoma \[DDLPS\]). Pathology review and confirmation of diagnosis will occur at the site enrolling the patient on this study * Dose expansion cohort: Patients must have histology diagnosis of LMS. Pathology review and confirmation of diagnosis will occur at the site enrolling the patient on this study * Dose escalation cohort: Patients must have evaluable disease that is amenable to biopsy * Dose expansion cohort: Patients must have disease which is measurable at study entry according to RECIST 1.1 criteria and amenable to biopsy * Patients must have been treated with at least 1 prior line of t