Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Brief summary
Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA for identification of pts who could benefit from a personalized treatment.
Detailed description
Two ultrasound-guided biopsies obtained to be stored in RNAlater® for DNA and RNA purification. A 3rd biopsy for histology is paraffin embedded. SNP-array (Affymetrix Cytoscan HD) from DNA (tumor) is performed to identify copy number changes. Whole exome sequencing (WES) from DNA (tumor and blood) will be performed using sequence capture, SureSelect v5 (Agilent) and Illumina HiSeq2500 to call tumor specific mutations. Expression levels of therapeutic targets are revealed by expression Array from tumor RNA. In addition to the expression array, RNA-seq (Nugens Ovation RNA-seq system v2) is performed to investigate whether chromosomal translocations were the reason for tumor specific expression of an oncogene. Results will be reviewed by a tumor board. Patients with specific genetic profiles that can be targeted with marketed drugs or drugs under development are offered such treatment. PFS from the treatment is compared to PFS of the most recent standard treatment (PFS ratio).
Interventions
PROCEDURETumor biopsy
Biopsy of lesion for molecular characterization
Sponsors
Ulrik Lassen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Solid tumor * No standard treatment option * PS 0-1 * Lesion assessable for biopsy * Measurable disease * Informed consent
Exclusion criteria
* Life expectancy \< 3 months * Bone marrow suppression * Abnormal renal or hepatic function * Serious concurrent medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median progression free survival (PFS) | Median time from date of randomization to date of progression or death, assessed up to 100 months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
Countries
Denmark
Contacts
CONTACTIda V Tuxen, MD
CONTACTUlrik Lassen, MD, PH.D.
PRINCIPAL_INVESTIGATORUlrik Lassen, MD, PH.D.
Rigshospitalet, Denmark
Outcome results
None listed