Clinical trial · Interventional
Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma
A Phase 2, Single Arm, Multi Center Trial Evaluating the Efficacy of the COmbination of Sirolimus and cYclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and chOndrosarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient survival. Current treatment options consist of wide surgical resection, however for patients with a local recurrence or metastatic disease the outcome is poor. New treatment options being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR) inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma treated with mTOR inhibitors have been conducted and they show promising results. From these studies the investigators can conclude that the combination of an mTOR inhibitor with cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according to a common protocol with the combination of sirolimus and cyclophosphamide using the growth modulation index for evaluation in the current clinical study protocol.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Conventional Chondrosarcoma | — | UNRESOLVED | — |
| Dedifferentiated Chondrosarcoma | Dedifferentiated Chondrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Mesenchymal Chondrosarcoma | Mesenchymal Chondrosarcoma | ONTOLOGY_EXACT | 0.90 |
| Myxoid Liposarcoma | Myxoid Liposarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sirolimus and cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sirolimus and cyclophosphamide
- description
- combining sirolimus 4mg daily orally and cyclophosphamide 200mg day 1 to 7 and 15 to 21 orally in a 4 week schedule
- interventionNames
- Drug: sirolimus and cyclophosphamide
Primary outcomes (1)
- measure
- The time to progression after start of treatment combination treatment of sirolimus and cyclophosphamide
- timeFrame
- 16 weeks
Secondary outcomes (5)
- measure
- Comparing pre-treatment tumor material and tumor material taken during treatment using immunohistochemistry to compare activation of the pS6, Bcl-2 and mTor pathway and DNA analysis for taqman analysis to search for hotspot mutations.
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven conventional chondrosarcoma * Or pathologically proven myxoid liposarcoma with PIK3CA mutation or Phosphatase and tensin homolog (PTEN) loss * Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma * Patient is 18 years and up * Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months * Written signed informed consent * Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L) * Availability of archival tumor material for central review or be able to perform a 3 core fresh biopsy * Ability to adhere to the study visits and all protocol requirements Exclusion Criteria: * Previously treated with an mTOR inhibitor * Known to be allergic to cyclophosphamide * Life expectancy of less than 3 months * No measurable lesions according to RECIST 1.1 * Eastern cooperative oncology group (ECOG) Performance status \>2 * Major surgery less than 4 weeks prior to start of treatment * Known human immunodeficiency virus (HIV) positivity * A decreased renal function with calculated glomerular filtration rate (GFR) \< 30ml/min * Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to a target lesion within 21 days prior to the first dose of study drug * Pregnant or lactating women * Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer
References
Publications (0)
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