Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma
NCT02517918
ABOUT THIS STUDY
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Adult Trials: 18+ Years
1. Histology:
- Advanced solid tumor with radiologically proven bone metastasis, (dose escalation part)
- Patients with osteogenic osteosarcoma (dose escalation part and expansion cohort) histologically confirmed by central review
2. Metastatic or unresectable locally advanced disease, not eligible for alternative local treatment (radiotherapy for instance)
3. Age > 18 years for patients with solid tumor and ≥ 13 years for patients with osteosarcoma
4. ECOG, performance status ≤ 1
5. Life expectancy > 3 months
6. Measurable disease according to RECIST v1.1. At least one site of disease must be uni-dimensionally ≥ 10 mm
7. Patients must have histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors, which are not amenable to standard treatment, including for patients with osteosarcoma conventional agents such as anthracyclines, platinum salts, ifosfamide and/or methotrexate
8. At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy
9. Adequate haematological, renal, metabolic and hepatic function:
- Haemoglobin ≥ 10 g/dl (patients may have received prior red blood cell transfusion, if clinically indicated); leucocytes ≥ 3 x 10^9/l, absolute neutrophil count ≥ 1.5 x 10^9/l, and platelet count ≥ 120 x 10^9/l.
- Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x upper limit of normality (ULN)
- Total bilirubin ≤ 1.5 x ULN
- Calculated creatinine clearance > 40 ml/min/1.73 m² (according to MDRD formula)
- Creatine phosphokinase ≤ 2.5 x ULN
- Albumin > 25 g/l
10. No prior or concurrent malignant disease diagnosed or treated in the last 2 years except adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
11. Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2) according to the NCI-CTCAE, version 4
12. Patients with a French social security in compliance with the French law relating to biomedical research
13. Voluntarily signed and dated written informed consent prior to any study specific procedure
14. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six months after discontinuation of treatment
1. Previous treatment with sirolimus
2. Concomitant diseases/conditions:
- Clinically significant and/or rapidly accumulating ascites, pericardial and/or
pleural effusions
- Unstable cardiac disease, pulse oximetry saturation < 90% at rest
- Clinically significant immunodeficiency, such as HIV or active Hepatitis B or C
- History of auto-immune disease, transplantation
3. Central nervous system malignancy
4. Men or women of childbearing potential who are not using an effective method of
contraception; women who are pregnant or breast feeding
5. Patients receiving any substances that are inhibitors or inducers of CYP450 3A4
6. Ongoing or recent (<6 weeks) dental problem, including any severe tooth or jaw
infection (mandible and maxilla), dental trauma, dental or stomatological surgery
(implants). Current dental cares are allowed
7. History of maxillary osteonecrosis or delayed healing after dental surgery
8. Participation to a study involving a medical or therapeutic intervention in the last
30 days
9. Previous enrolment in the present study
10. Patient unable to follow and comply with the study procedures because of any
geographical, familial, social or psychological reasons
11. Known hypersensitivity to any involved study drug or any of its formulation components
12. Patients receiving live vaccines within 30 days prior to the first dose of study
therapy and while participating in study
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| Descriptive Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma | ||||||||
| Official Title ICMJE | Metronomic Cyclophosphamide and Methotrexate Combined With Zoledronic Acid and Sirolimus in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma. A Phase Ib Study From the French Sarcoma Group | ||||||||
| Brief Summary | This is a prospective open-labeled phase I trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the Maximum Tolerated Dose (MTD) is established. | ||||||||
| Detailed Description | The dose escalation part of the trial will be concerned on adults with advanced solid tumor with bone metastasis and young and adult patients with unresectable locally advanced or metastatic osteosarcoma. The Expansion cohort will be conducted on young and adult patients with unresectable locally advanced or metastatic osteosarcoma. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||
| Condition ICMJE |
| ||||||||
| Intervention ICMJE | Drug: Sirolimus combined with CP, MT and ZA
Cyclophosphamide, Methotrexate and Sirolimus will be administrated orally. Zoledronic Acid will be administrated by infusion (IV). Trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the MTD is established. Other Name: Endoxan, Methotrexate, Rapamune, Zoledronic acid | ||||||||
| Study Arms ICMJE | Experimental: Sirolimus combined with CP, MT and ZA
Drug : Metronomic Cyclophosphamide, Methotrexate, Sirolimus, Zoledronic acid Assessment of the maximum tolerated dose of sirolimus Cyclophosphamide, Methotrexate and Sirolimus will be administrated orally. Zoledronic Acid will be administrated by infusion (IV). Intervention: Drug: Sirolimus combined with CP, MT and ZA | ||||||||
| Publications * | Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 26 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 2021 | ||||||||
| Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT02517918 | ||||||||
| Other Study ID Numbers ICMJE | IB 2014-01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Institut Bergonié | ||||||||
| Study Sponsor ICMJE | Institut Bergonié | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Institut Bergonié | ||||||||
| Verification Date | February 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||