Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas

Who is this study for? Patients with Sarcomas
What treatments are being studied? Disulfiram+Copper Gluconate+Liposomal Doxorubicin (Doxil)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to test the safety of combining the disulfiram (DSF) and copper gluconate (Cu) to liposomal doxorubicin to treat patients with sarcomas that recurred or did not respond to initial treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:

• Must have histologically confirmed relapsed or refractory sarcoma.

• Must have measurable disease by RECIST criteria at study enrollment

• Performance status of Karnofsky/Lansky ≥50%

• 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

• Must be able to swallow pills or consume the contents of the DSF and Capsules sprinkled on food.

• Participants, or parent/guardians for participants \<18 years old (yo), must have the ability to understand and the willingness to sign a written informed consent document.

• 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 normal organ and marrow function criteria above).

• Participants ≥18yo must agree to pre-and post-treatment core needle tumor biopsies. For participants \<18yo biopsies are optional. 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.

• Must abstain from sexual intercourse or used appropriate, highly-effective birth control measures.

Locations
United States
Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Matteo Trucco, MD
truccom@ccf.org
+1 216-444-8950
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 24
Treatments
Experimental: DSF/Cu
A 3+3 dose escalation design will be used to determine the recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin. There will be a 7 day lead-in week of Disulfiram (DSF)/Copper Gluconate (Cu). The disulfiram and the copper gluconate will be dosed once a day. Disulfiram in the morning and copper gluconate in the evening. Same total daily dose every 4 week (28 days) administration of liposomal doxorubicin (Doxil) 30mg/m2/dose IV~Cycle length: 28 days Maximum 12 cycles
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov