Disulfiram and Cisplatin in Refractory TGCTs.

NCT03950830 | Completed Phase 2

• 1 other identifier: GCT-SK-006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Non-randomized, open-label, single center trial to assess efficacy (as measured by overall response rate (ORR) by RECIST 1.1 of disulfiram and cisplatin in patients with multiple relapsed/refractory germ cell tumors (GCTs).

Conditions

Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Overall response rate by RECIST 1.1

  24 months

Secondary Outcomes (2)

• Progression-free survival

  24 months

• Overall survival

  24 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Cisplatin 50mg/m2 day 1 and 2, every 3 weeks, Disulfiram 400mg daily, continuously

Drug: Disulfiram

Interventions

Disulfiram DRUG

Disulfiram 400mg daily, continuously

Also known as: Antabus

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent .
• Men aged 18 years or older.
• ECOG performance status: 0-1.
• Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma.
• Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer.
• Multiple relapsed/refractory GCTs (at least 2 lines of previous chemotherapy and/or patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy.
• Primary mediastinal GCTs in first relapse.
• Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator.
• RECIST 1.1 Measurable disease.
• Adequate hematologic function defined by ANC \> 1500/mm3, platelet count \> 100 000/mm3 and hemoglobin level \> 9g/dl.
• Adequate liver function defined by a total bilirubin level \< 1.5 ULN, and ALT, AST \< 3 ULN or \< 5 in case of liver metastases. For subjects with Gilbert's syndrome bilirubin \> 1.5 × ULN is allowed if no symptoms of compromised liver function are present.
• Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance \> 50 ml/min. Cockcroft formula: CLcr = \[(140-age) x weight (Kg)\]/\[72 x creat (mg/dl)\].
• At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry.
• At least 4 weeks must have elapsed since the last major surgery.
• Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1.

You may not qualify if:

• Addiction to alcohol or drugs.
• Other prior malignancy except successfully treated nonmelanoma skin cancer .
• Need for metronidazole, warfarin and/or theophylline medication, the metabolism of which is likely influenced by disulfiram.
• Patients who are taking medications metabolized by cytochrome P450 2E1, including chlorzoxazone or halothane and its derivatives.
• Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy.
• Female patients.
• Patients infected by the Human Immunodeficiency Virus (HIV).
• Patients with other severe acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with study treatment, or which, in judgment of the investigator, would make the patient inappropriate for entry into this study.
• Inability of oral intake, or drug absorbtion (e.g. malabsorption syndrome).
• Hypersensitivity to any compound of the drug.
• Sexually active men not using highly effective birth control if their partners are women of child-bearing potential.

Sponsors & Collaborators

• National Cancer Institute, Slovakia: lead

Study Sites (1)

National Cancer Institute

Bratislava, 83310, Slovakia

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Study Officials

• Michal Mego, Prof

  National Cancer Institute, Slovakia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Non-randomized, open-label, single center trial to assess efficacy (as measured by overall response rate of disulfiram and cisplatin in patients with multiple relapsed/refractory germ cell tumors (GCTs).

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: May 15, 2019
• Study Start: May 14, 2019
• Primary Completion: September 30, 2021
• Study Completion: January 31, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)