IRB Study Number 22-699
Status Recruiting
Institutes Taussig Cancer Institute, Pediatric Institute
Description
2.1 Primary Objective
To determine the feasibility, safety, tolerability and recommended phase 2 dose of DSF/Cu in combination with liposomal doxorubicin for the treatment of relapsed/refractory sarcomas in pediatric, adolescent and adult patients.
2.2 Secondary Objective(s)
Obtain preliminary data on treatment response to DSF/Cu in combination with liposomal doxorubicin including tumor response on imaging by RECIST criteria and overall and event-free survival. - Obtain pharmacokinetic data on DSF/Cu in patients ≥18 years old after administration during the lead in week and after the administration of liposomal doxorubicin on Day 1 of cycle 1.
Inclusion Criteria
Subjects must have histologically sarcoma in relapsed or refractory or intolerant of existing therapies known to provide clinical benefit.
Subjects must have measurable disease by RECIST criteria at study enrollment.
Age: Subjects must be ≥18yo at the time of enrollment
Performance status of Karnofsky/Lansky ≥50%
[See Appendix].
- Subjects must have normal organ and marrow function as defined below:
Absolute neutrophil count ≥ 1,000/mcL
Platelet count ≥ 100,000/mcL
Total bilirubin within normal institutional limits
AST (SGOT) ≤ 2.5 X institutional upper limit of normal
ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
Serum Creatinine ≤1.5X institutional limit of normal
Cardiac Shortening fraction of 27% or Ejection fraction of ≥ 50% on echocardiogram
QTc ≤ 480msec on EKG.
Patients must have normal serum copper levels and serum cerulopasmin >17mg/dL
Patient must be able to swallow pills or consume the contents of the DSF and Cu capsules sprinkled on food.
Patients must have the ability to understand and the willingness to sign a written informed consent document.
Patients must abstain from alcohol during study.
Prior treatment toxicities must have stabilized or resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia, neuropathy and hematologic criteria (must meet criteria #5 above).
Patients must agree to pre- and post-treatment core needle tumor biopsies. Biopsies will not be performed if deemed unsafe by interventional radiologists that will be performing the procedure and is not part of the study team to avoid bias. Fresh tissue is required for the analyses. Archived tissue unfortunately cannot be used.
Patient must abstain from sexual intercourse or used appropriate, highly-effective birth control measures.
Exclusion Criteria
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Patient has a history of allergy or hypersensitivity to any of the study drugs, their pharmaceutical class or any of their excipients. The patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of Liposomal Doxorubicin Prescribing Information package inserts or on the Investigator’s Brochure for DSF/Cu.
Patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity.
Patient is currently enrolled in any other clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of their sarcoma.
Any gastrointestinal disorders that will interfere with absorption of medications.
Patient is unwilling or unable to comply with study procedures.
Know condition preventing safe administration of copper such as a copper allergy or Wilson’s Disease.
Men who score >8 and women who score >4 on Alcohol Use Disorders Identification Test (AUDIT) questionnaire (See APPENDIX IV) .
PI feels participation in this study would be harmful or of no benefit to the patient.
