Germ Cell Tumor Clinical Trial
Official title:
Phase II Study of Disulfiram and Cisplatin in Refractory TGCTs.
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).
Germ-cell tumours (GCTs) are extraordinarily chemosensitive and resemble the clinical and biological characteristics of a model for the cure of cancer. Nonetheless, a small proportion of patients do not have a durable complete remission (CR) with initial chemotherapy. Only 20-40% of them will be cured with the use of platinum-containing standard-dose or high-dose salvage chemotherapy with autologous stem cell transplantation (ASCT). Patients who fail to be cured after second-line salvage therapy have an extremely poor prognosis and long term survival had been documented in <5%. Paclitaxel plus ifosfamide and cisplatin is considered as a standard salvage chemotherapy in relapsed good prognosis GCTs, however, up to 40% of favourable prognosis patients failed to achieve durable response to this combination, and therefore new treatment strategies are warranted. Previously, it was showed that cisplatin resistant TGCTs overexpress ALDH isoforms and inhibition of ALDH activity by disulfiram is associated with reconstitution of cisplatin sensitivity. Cisplatin-resistant TGCTs exhibited increased sensitivity to ALDH inhibitor disulfiram in vitro. Although Disulfiram (Antabuse) is an approved drug to support the treatment of chronic alcoholism, it may serve as an antitumor agent suitable for the drug repurposing in combination therapy in order to inhibit ALDH activity thus overcoming a cisplatin resistance in refractory TGCTs. Indeed, disulfiram in combination with cisplatin very efficiently eradicated platinum-resistant NTERA-2 model spheroids and significantly inhibited xenograft growth in vivo in our experimental system. Based on aforementioned data, investigators suggest that there is strong rationale to inhibit ALDH in TGCT. Investigators hypothesize that inactivation of ALDH by disulfiram recover cisplatin sensitivity in patients with progressing or relapsing germ cell cancer. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06133543 -
Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
|
N/A | |
| Terminated |
NCT00369291 -
CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
|
Phase 1 | |
| Terminated |
NCT00198172 -
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors
|
Phase 2 | |
| Recruiting |
NCT05874063 -
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
|
Phase 3 | |
| Completed |
NCT03194906 -
Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors
|
Phase 2 | |
| Completed |
NCT01466231 -
Everolimus in Refractory Testicular Germ Cell Cancer
|
Phase 2 | |
| Recruiting |
NCT04791228 -
A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03418844 -
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
|
N/A | |
| Recruiting |
NCT05889585 -
Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated With High-dose Chemotherapy and Autologous Stem Cell Transplant
|
||
| Recruiting |
NCT05394675 -
A Study of DS-9606a in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT03067181 -
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
|
Phase 3 | |
| Withdrawn |
NCT03960151 -
Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
|
Phase 2 | |
| Active, not recruiting |
NCT03158064 -
Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors
|
Phase 2 | |
| Recruiting |
NCT00898755 -
Collecting and Storing Tissue From Young Patients With Cancer
|
||
| Recruiting |
NCT04804007 -
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
|
Phase 2 | |
| Terminated |
NCT02988843 -
Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors
|
Phase 2 | |
| Recruiting |
NCT05259605 -
Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification
|
||
| Active, not recruiting |
NCT03638167 -
EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors
|
Phase 1 | |
| Recruiting |
NCT04308330 -
Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT03426865 -
Role of Axumin PET Scan in Germ Cell Tumor
|