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

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ClinicalTrials.gov Identifier: NCT02359474
Recruitment Status : Active, not recruiting
First Posted : February 10, 2015
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Eric Kampmann, Ludwig-Maximilians - University of Munich

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: Trabectedin Genetic: DNA double-strand breaks Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trabectedin Combined With Regional Hyperthermia as Second Line Treatment for Adult Patients With Advanced Soft-tissue Sarcoma
Actual Study Start Date : December 19, 2014
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Trabectedin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Trabectedin with regional hyperthermia

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).

 Drug: Trabectedin
Other Name: Yondelis

Genetic: DNA double-strand breaks
The rationale for combining Tr and RHT is based on immune mechanisms induced by local heating of which are independent of the anti-tumor effects of Tr. Recent results demonstrate that an acute inflammation at the site of the heated tumor area and "danger signals" are responsible for immune reactions against tumor and metastases (Frey 2012). Abscopal effects after local radiation of tumors with response of distant metastases are induced by similar mechanisms like heat stress (Formenti 2013, Golden 2015). The long-term results for soft-tissue sarcoma are consistent with abscopal effects induced by RHT in a randomized trial compared to chemotherapy alone (Issels 2018).
Active Comparator: Trabectedin
Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease.
 Drug: Trabectedin
Other Name: Yondelis

Genetic: DNA double-strand breaks
The rationale for combining Tr and RHT is based on immune mechanisms induced by local heating of which are independent of the anti-tumor effects of Tr. Recent results demonstrate that an acute inflammation at the site of the heated tumor area and "danger signals" are responsible for immune reactions against tumor and metastases (Frey 2012). Abscopal effects after local radiation of tumors with response of distant metastases are induced by similar mechanisms like heat stress (Formenti 2013, Golden 2015). The long-term results for soft-tissue sarcoma are consistent with abscopal effects induced by RHT in a randomized trial compared to chemotherapy alone (Issels 2018).


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: planned after 46 events after start of recruitment which are expected to occur after 27 month ]

Secondary Outcome Measures :
  1. Radiological response according to RECIST [ Time Frame: planned after 46 events after start of recruitment which are expected to occur after 27 month ]
  2. Overall Survival (OS) [ Time Frame: planned after 46 events after start of recruitment which are expected to occur after 27 month ]
  3. Treatment related toxicity (hematological, renal, hepatic, others) [ Time Frame: planned after 46 events after start of recruitment which are expected to occur after 27 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359474


Locations
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Germany
Ludwig-Maximilians University of Munich, Klinikum Großhadern
Munich, Bavaria, Germany, 81377
Helios Klinikum Bad Saarow
Bad Saarow, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Helios Klinikum Berlin-Buch
Berlin, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: Rolf Issels, MD Ludwig-Maximilians - University of Munich
More Information
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Responsible Party: Eric Kampmann, Dr. med., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02359474    
Other Study ID Numbers: HyperTET
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023
Keywords provided by Eric Kampmann, Ludwig-Maximilians - University of Munich:
high-risk soft tissue sarcoma
trabectedin
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Trabectedin
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents