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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021792-81 | EudraCT Number |
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To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response").
To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles).
Multi-center, combination phase II study, open-label, non-comparative, non-randomized.
All progressive or recurrent solid tumours will be included in the Phase II study, provided there are no curative options anymore.
Total expected number of patients (minimum maximum): 54 to 90 (2-stage design)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| traetment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib, Vinblastine, Cyclophosphamide , methotrexate , | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tumour efficacy | 3 YEARS |
| Measure | Description | Time Frame |
|---|---|---|
| Safety AND Pharmacodynamic Study | 3 YEARS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | 13354 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30319400 | Derived | Verschuur A, Heng-Maillard MA, Dory-Lautrec P, Truillet R, Jouve E, Chastagner P, Leblond P, Aerts I, Honore S, Entz-Werle N, Sirvent N, Gentet JC, Corradini N, Andre N. Metronomic Four-Drug Regimen Has Anti-tumor Activity in Pediatric Low-Grade Glioma; The Results of a Phase II Clinical Trial. Front Pharmacol. 2018 Sep 27;9:00950. doi: 10.3389/fphar.2018.00950. eCollection 2018. | |
| 22156656 |
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| Derived |
| Andre N, Abed S, Orbach D, Alla CA, Padovani L, Pasquier E, Gentet JC, Verschuur A. Pilot study of a pediatric metronomic 4-drug regimen. Oncotarget. 2011 Dec;2(12):960-5. doi: 10.18632/oncotarget.358. |
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D014747 | Vinblastine |
| D003520 | Cyclophosphamide |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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