Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin (HyperTET)

Ludwig Maximilian University of Munich

Status and phase: Active, not recruiting; Phase 2

Conditions: Sarcoma

Treatments: Genetic: DNA double-strand breaks; Drug: Trabectedin

Study type: Interventional

Funder types: Other

Identifiers

NCT02359474

HyperTET

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Trabectedin with regional hyperthermia

Experimental group

Description:

Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease. Additional treatment with regional hyperthermia (RHT): RHT treatment of the tumor area and the surrounding tissue (41-44°C for 60 min treatment time) is applied at the end of Trabectedin infusion (+/- 4 hrs).

Treatment:

Drug: Trabectedin

Genetic: DNA double-strand breaks

Trabectedin

Active Comparator group

Description:

Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease.

Treatment:

Drug: Trabectedin

Genetic: DNA double-strand breaks