SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00625092

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Phase I Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs after surgery may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in treating patients with peritoneal cancer.

NCT00625092 Peritoneal Cavity Cancer
MeSH: Peritoneal Neoplasms Fever
HPO: Fever

4 Interventions

Name: fluorouracil

Description: Post-operative day 1 and day 2, 600mg/m^2 intraperitoneal (IP) held for 23 hours

Type: Drug

Hyperthermic Treatment

Name: leucovorin calcium

Description: Day 0 200 mg/m^2 intraperitoneal held for 2 hours

Type: Drug

Hyperthermic Treatment

Name: oxaliplatin

Description: Day 0 hyperthermic intraperitoneal oxaliplatin held for 30 minutes - assigned dose level: Levels 1 through 7 - 300 to 600 mg/m^2

Type: Drug

Hyperthermic Treatment

Name: cytoreductive surgery

Description: Day 0 Cytoreductive surgery is a systematic attempt to remove all or nearly all peritoneal nodules.

Type: Procedure

Hyperthermic Treatment


Primary Outcomes

Measure: Maximum tolerated dose of hyperthermic intraperitoneal oxaliplatin

Time: 30 Days Post Treatment

Secondary Outcomes

Description: Using the Functional Assessment of Cancer Therapy for Colorectal Cancer (FACT-C) and SF-36 (Quality of Life Evaluation in Dialysis Patients) questionnaires, the quality of life following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPC) will be reported and compared to the preoperative baseline.

Measure: Changes in quality-of-life

Time: Baseline and at 4, 8, and 12 months

Measure: Overall survival

Time: 1 Year and 5 Years

Measure: Time to Disease Progression

Time: Monthly

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 D312N

The infusion will be repeated on day 2. Blood samples are collected prior to surgery for pharmacogenetic studies and analyzed for the presence of genetic polymorphisms in the XPD and XRCC1 DNA repair genes and the GSTP1 and GSTM1 glutathione-S-transferase enzymes (i.e., XPD, Asp312Asn, XPD K751Q, XRCC1 Arg399GIn, XRCC1 Arg399Q, GSTP1 l105V, and GSTM1 DEL). --- Asp312Asn ---


2 K751Q

The infusion will be repeated on day 2. Blood samples are collected prior to surgery for pharmacogenetic studies and analyzed for the presence of genetic polymorphisms in the XPD and XRCC1 DNA repair genes and the GSTP1 and GSTM1 glutathione-S-transferase enzymes (i.e., XPD, Asp312Asn, XPD K751Q, XRCC1 Arg399GIn, XRCC1 Arg399Q, GSTP1 l105V, and GSTM1 DEL). --- Asp312Asn --- --- K751Q ---



HPO Nodes


HPO:
Fever
Genes 252
CYBB IL10 TET2 MYD88 IL12A IL12B PRSS1 TREX1 IBA57 NLRP12 POU6F2 SLC29A3 ERCC2 GALC ERCC3 ERCC4 ZBTB16 ABL1 ERCC5 PRTN3 DIS3L2 CRLF1 RNF168 HLA-B SPINK1 ACAT1 AVP ERAP1 HLA-DPA1 AVPR2 HLA-DPB1 CYP11B2 TMEM165 HLA-DRB1 SPTA1 CYP21A2 CYBC1 SPTB CFTR NCF1 PSMB4 GATA2 BLNK PSMB8 SCYL1 PSMB9 PEX6 TCIRG1 SRP54 SLCO1B3 UNC13D PTPN22 IKZF1 NCF2 TSC1 NCF4 TSC2 CCND1 GCH1 HMGCL BCL2 TMEM173 BCL6 ADA BCR ADAR TRIP13 ADA2 F5 LYST DDB2 KLRC4 GFI1 MEFV NLRC4 RYR1 STAT3 STAT4 STAT5B NOD2 STIM1 JAK2 LPIN1 IFIH1 MALT1 PTPN3 DST FBP1 GLA STXBP2 GPC3 BRCA2 KLHL7 POMP PTS KCNJ1 PIK3R1 BTK RNASEH2C EIF2B4 MIF EIF2B3 EIF2B2 EIF2B5 SCNN1A SCNN1B NGF SCNN1G FIP1L1 AK2 CCR1 C4A BCL10 ABCC2 NME1 QDPR RAB27A IL23R NOTCH3 ALPL PML COL1A1 PMM2 MPL PMP22 RNASEH2B CACNA1A NPM1 RAG1 RAG2 CACNA1S TCF4 RANBP2 KRT8 TCF3 HTR1A RARA ANK1 WAS WIPF1 MLX SH2B3 KRT18 RB1 RNASEH2A CALR GPR35 NTRK1 SH3KBP1 NUMA1 SLC19A3 IRF8 WT1 ELP1 BIRC3 XIAP SAMHD1 XPA CHD7 XPC ADAMTS13 LBR REST PSTPIP1 NABP1 RUNX1 FAS AQP2 SLCO1B1 TBL1XR1 EDA ATP13A2 NLRP3 POLR3A SLC4A1 CASK IFNGR1 HAVCR2 MST1 RMRP LIFR ORAI1 LIG4 TH LIPA BCAP31 ATP6 SLC11A1 IL36RN SLC12A1 SLC12A3 COX1 COX2 COX3 IGH DCLRE1C LACC1 CD27 TRIM28 IL12A-AS1 EIF2B1 GYPC IGHM BTNL2 ND1 ND2 ND3 ND4 TLR4 ND5 ND6 LPIN2 CHEK2 PRKAR1A LRRC8A ELANE ZFHX2 CD79A CD79B UBAC2 FOXP1 TRNF TRNH CTLA4 TRNK IGLL1 TRNL1 ATM NGLY1 TNFAIP3 TRNQ TNFRSF1A ATP1A2 ATP1A3 TRNS1 TRNS2 TRNV TRNW HBB STX11 IL2RG G6PD IL6 EPB41 GAA H19 PRNP TP53 EPB42 MVK IL7R CYBA