Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone.

Launched by MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH · Mar 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with myxoid liposarcoma, a type of cancer that affects soft tissue. The trial is testing the combination of two medications: trabectedin (T) and pioglitazone (P). It aims to see if this combination is more effective than using trabectedin alone in patients who have stable disease after receiving at least four cycles of trabectedin treatment. The study will take place in two stages. The first stage will evaluate the effectiveness of the combination treatment at a single center in Italy. If promising results are found, the second stage will involve multiple centers and will compare the two treatment options in a randomized manner.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with myxoid or round cell liposarcoma. They should have stable disease after previous treatment and have recovered from any side effects of earlier therapies. However, women who are pregnant or breastfeeding, as well as those with certain health conditions (like serious infections, unstable heart issues, or other cancers), will not be able to participate. For those who join the study, they can expect regular monitoring and care as the trial progresses. Overall, this trial represents hope for better treatment options for patients dealing with this challenging type of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of myxoid/round cell liposarcomas
• • 2. Histological diagnosis confirmation by a reference centre
• • 3. Age ≥ 18 years
• • 4. ECOG PS ≤2
• • 5. One or more previous systemic treatments employing anthracyclines +/- ifosfamide (unless one or both are clinically contraindicated)
• • 6. Four or more previous cycles of T with a stable disease as defined by RECIST criteria
• • 7. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or higher
• • 8. Provision of signed informed consent
• Exclusion Criteria:
• • 1. Pregnant or breast-feeding women
• • 2. Partial response or progression disease as per RECIST criteria to the previous treatment with T
• • 3. Inadequate haematological, renal and liver functions
• • 4. History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse
• • 5. Known central nervous system (CNS) metastases
• • 6. Active viral hepatitis or chronic liver disease
• • 7. Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias
• • 8. Active major infection
• • 9. Other serious concomitant illnesses