Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Trabectedin

Criteria

Inclusion Criteria:

• Age > 18 years

• Histologically confirmed STS (primary or recurrent), except: Ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), GIST, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma

• Patients after failure of first-line chemotherapy (anthracyclines with/without ifosfamide) with or without RHT

• Progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome

• After macroscopic incomplete resection or marginal resection (tumor-free margins < 1 cm)

• Prior chemotherapy, including anthracyclines with/without ifosfamide (with or without RHT) or patients who cannot be given these medicines

• At least one tumor manifestation which is eligible for hyperthermia

• Performance status (ECOG) 0,1 or 2

• More than 3 weeks from last treatment

• Neutrophil count ≥ 1,5 G/l, hemoglobin ≥ 9 g/dl, platelets ≥ 100 G/l

• Albumin ≥ 25 g/l, total bilirubin ≤ 1 x ULN, ALT/AST ≤ 2.5 x ULN, AP ≤ 2.5 x ULN, Cockroft and Gault's calculated creatinine clearance ≥ 30 ml/min, CPK ≤ 2.5 x ULN

• Patients with the ability to follow study instructions and likely to attend and complete all required visits

• Written informed consent of the subject

Exclusion Criteria:

• Uncontrolled infection (e.g. active viral hepatitis)

• Unstable cardiac status

• Peripheral neuropathy > grade 2

• Known or persistent abuse of medications, drugs or alcohol

• Other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ)

• Prior therapy with Tr or known history of hypersensitivity to drugs with a similar chemical structure

• Pregnancy or breast-feeding

• Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration

• Uncontrolled CNS-metastases

• Medical or technical impossibility for hyperthermia to heat the major target lesion