Metastatic Solid Tumors (Any Localization)
Conditions
Brief summary
The primary objective of the study is to use high throughput molecular analysis (CGH Array and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order to improve the progression free survival compared to the previous treatment line. The secondary objectives are to investigate clinical practical feasibility of such technics, to potentially improve the overall survival of patients and to describe molecular portrait of Phase 1 candidates.
Interventions
PROCEDURETumoral biopsy
Every enrolled patient undergoes tumoral biopsy
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Solid tumors ; Stade IV ; Local relapse or metastatic ; Uncurable * Age \> 6 months * PS 0/1 or Lansky play scale \>= 70% * Minimum one treatment line, no limit in the prior number of treatment line * Evaluable or measurable disease
Exclusion criteria
* Life expectancy \< 3 months * Carcinomatous meningitis * Symptomatic or progressive radiologic brain metastasis for non-CNS tumors * Polynuclear neutrophil \< 1 x 10\^9/L * Platelets \< 100 x 10\^9/L * Hemoglobin \< 90 g/L * ALT/AST \> 2.5 N * bilirubin \> 1.5 N * Creatinine \>1.5 N * Calcemia \> ULN * Phosphate \> ULN * Coagulation anomaly non-indicated for biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen | From date of start of targeted treatment oriented by MOSCATO until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year | Progression according to RECIST criteria or clinical progression or death of any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient who received a targeted treatment oriented by molecular profiling | From the start to the end of enrollment, up to 3 years | Number of patient who received a targeted treatment oriented by molecular profiling |
| Progression free Survival, Overall Survival and Response Rate | Until progression, up to 1 year | Comparison of Progression Free Survival, Overall Survival and Response Rate between patients with targeted treatment and others enrolled patients. |
Countries
France
Outcome results
None listed