Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma
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ClinicalTrials.gov Identifier: NCT02821507 |
Recruitment Status :
Recruiting
First Posted : July 1, 2016
Last Update Posted : February 25, 2020
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Condition or disease | Intervention/treatment | Phase |
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Conventional Chondrosarcoma Myxoid Liposarcoma Mesenchymal Chondrosarcoma Dedifferentiated Chondrosarcoma | Drug: sirolimus and cyclophosphamide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 105 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | June 2014 |
Estimated Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | June 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: sirolimus and cyclophosphamide
combining sirolimus 4mg daily orally and cyclophosphamide 200mg day 1 to 7 and 15 to 21 orally in a 4 week schedule
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Drug: sirolimus and cyclophosphamide |
- The time to progression after start of treatment combination treatment of sirolimus and cyclophosphamide [ Time Frame: 16 weeks ]
- 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. [ Time Frame: 8 weeks ]
- Register adverse events to evaluate the patient safety and tolerability of the sirolimus and cyclophosphamide combination in myxoid liposarcoma and chondrosarcoma [ Time Frame: every 8 weeks until progression (average of 1 year) ]
- To evaluate the response according to response evaluation criteria in solid tumors (RECIST) 1.1 [ Time Frame: every 8 weeks until progression (average of 1 year) ]
- Using the growth modulation index (GMI) to evaluate treatment efficiency [ Time Frame: every 8 weeks until progression (average of 1 year) ]GMI: Time to progression during sirolimus/cyclophosphamide treatment (TTP2) divided by time to progression before start of this treatment TTP1
- The overall survival after start of treatment till death [ Time Frame: every 8 weeks until progression (average of 1 year) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT02821507
Contact: Hans Gelderblom, Prof | a.j.gelderblom@lumc.nl |
Netherlands | |
LUMC | Recruiting |
Leiden, Netherlands, 2333ZA | |
Contact: Hans Gelderblom, Prof a.j.gelderblom@lumc.nl | |
Spain | |
Hospital de Sant Pau | Recruiting |
Barcelona, Spain | |
Contact: A López Pousa | |
Hospital Val d'Hebron | Recruiting |
Barcelona, Spain | |
Contact: C Valverde | |
CIO Clara Campal | Recruiting |
Madrid, Spain | |
Contact: J Rodriguez | |
Hospital Universitario Virgen del Rocío | Recruiting |
Sevilla, Spain | |
Contact: J Martin Broto | |
Hospital Universitario y Politécnico de La Fe | Recruiting |
Valencia, Spain | |
Contact: R Diaz-Beveridge | |
Instituto Valenciano de Oncología | Recruiting |
Valencia, Spain | |
Contact: J Lavernia |
Principal Investigator: | Hans Gelderblom, Prof | Leiden University Medical Center |
Responsible Party: | HansGelderblom, Prof A.J. Gelderblom, Leiden University Medical Center |
ClinicalTrials.gov Identifier: | NCT02821507 |
Other Study ID Numbers: |
COSYMO |
First Posted: | July 1, 2016 Key Record Dates |
Last Update Posted: | February 25, 2020 |
Last Verified: | February 2020 |
Liposarcoma Chondrosarcoma Liposarcoma, Myxoid Chondrosarcoma, Mesenchymal Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Neoplasms, Connective Tissue Sirolimus Cyclophosphamide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |