Status:
COMPLETED
Rational Therapeutics Based on Matched Tumor and Normal Tissue
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
European Commission
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your ...
Detailed Description
If you agree to take part in this study, your tumor tissue and blood samples will be tested for molecular profiling. Molecular profiling is the classification of tissue based on the expression of cert...
Eligibility Criteria
Inclusion
- Informed consent
- Any histologic type of metastatic cancer, (except for lung and brain at US sites), in which histologic normal counterpart can be obtained. See list of cancer types included in the trial in Appendix 1.
- Progression by RECIST (Response Evaluation Criteria In Solid Tumors) or other criteria on at least one prior regimen for advanced disease
- Ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart
- Age from 18 years
- Life expectancy of at least 3 months
- ECOG Performance status of 0 to 1
- Measurable or evaluable disease according to RECIST 1.1 criteria
- For US sites only: advanced cancer patients that have exhausted all effective therapy for their disease and have progressed after previous line of therapy (documented disease progression under last treatment received) and conventional methods of assigning new therapy would not be expected to increase survival by more than 3 months.
Exclusion
- For US sites only: Any patient that might require a lung or brain biopsy are excluded
- Alteration of organ function or hematopoietic function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) \>2.5 x upper limit of normal (ULN), except for patients with liver metastases, for which AST and ALT \> 5.0 ULN is the exclusion criteria.
- Bilirubin \> 2.0 ULN to allow for Gilberts
- Polynuclear neutrophil \< 1.5 x 109/L
- Platelets \< 100 x 10 9/L
- Hemoglobin \< 90 g/L
- Creatinine \> 1.5 ULN
- i. Calcemia \> 1.5 ULN g. Phosphatemia \> 1.5 ULN
- Coagulation abnormality prohibiting a biopsy
- Symptomatic or progressive brain metastases detected by radio imaging, or meningeal
- Patient who received a personalized therapeutic treatment based on molecular anomaly during the treatment period immediately prior to the WINTHER directed treatment (defining the PFS1). Hormonal therapy may be continued during WINTHER suggested therapy. The exclusion of prior matched targeted therapy includes but is not limited to all targeted therapeutics that are EMA approved and genomically matched to patients. If there are questions about whether or not a prior therapy is a matched targeted treatment it will be agreed on by discussion between PIs who are also Clinical Management Committee members; the resolution should take place prior to starting Winther directed treatment.
Key Trial Info
Start Date :
November 4 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 11 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02272595
Start Date
November 4 2014
End Date
January 11 2022
Last Update
February 15 2022
Active Locations (4)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Cancer Institute Gustave Roussy
Villejuif, France, 94805
3
Chaim Sheba Medical Center at Tel Hasomer
Ramat Gan, Israel
4
Vall D'Hebron University Hospital
Barcelona, Spain, 08035