SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation K751Q

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There are 2 clinical trials

Clinical Trials


1 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
Conditions
  1. Peritoneal Cavity Cancer
Interventions
  1. Drug: fluorouracil
  2. Drug: leucovorin calcium
  3. Drug: oxaliplatin
  4. Procedure: cytoreductive surgery
MeSH:Fever
HPO:Fever

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 ---

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

2 Phase II(Window) Preoperative Study of Olaparib With Cisplatin or With Durvalumab (MEDI4736) or Alone or no Treatment in Patients With Histologically Proven Squamous Cell Carcinoma of the Head and Neck Who Are Candidates for Surgery.

OPHELIA (OPHELIA (OlaParib and durvalumab in HEad and neck squamous celL carcInomA) trial is a Greek, investigator-initiated, randomized open-label window-of-opportunity phase II study. Patients with operable histologically documented squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx will be randomized between combination with durvalumab and olaparib, cisplatin and olaparib, monotherapy with olaparib or no treatment, before starting standard treatment.

NCT02882308
Conditions
  1. Squamous Cell Carcinoma of the Head and Neck
Interventions
  1. Drug: Olaparib
  2. Drug: Cisplatin
  3. Drug: Olaparib
  4. Drug: Durvalumab
MeSH:Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck
HPO:Carcinoma Squamous cell carcinoma

Single-nucleotide polymorphisms:ERCC2 Lys751Gln (T/G). --- Lys751Gln ---

Single-nucleotide polymorphisms: XPD Lys751Gln (A/C, C/C). --- Lys751Gln ---

Primary Outcomes

Measure: Investigation of the change in the tumour Ki-67 before and after treatment with the combination of olaparib + durvalumab or olaparib + cisplatin or olaparib monotherapy.

Time: At baseline and at the day of the surgery or 2nd biopsy (at days 23-29 days)

Secondary Outcomes

Measure: Objective response rate according to RECIST 1.1 criteria

Time: Imaging studies will be performed at baseline and on week 4

Measure: Pathologic complete response rate

Time: On week 4 only for operable patients

Measure: Metabolic response rate assessed by FDG-PET/CT scan (optional)

Time: At baseline, on week 4

Measure: Number of participants with tolerability to the treatment.

Time: From the 1st day of therapy and every week for 4 weeks maximum and 90 days after last therapy administration

Measure: Surgical complication rate

Time: Up to 30 days after surgery or the day of initiation of the next anticancer therapy

Measure: Mutations in genes associated with DNA repair

Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)

Measure: Expression of tissue biomarker: PARP1

Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)

Measure: Expression of tissue biomarker: BRACA1,2

Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)

Measure: Expression of tissue biomarker: ERCC1

Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)

Measure: Expression of tissue biomarker: PDL-1

Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)

Measure: Expression of tissue biomarker: TILs

Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)

Measure: Plasma methylation biomarker: PARP1 methylation in plasma cell-free DNA

Time: At baseline, a day before surgery and 90 days after surgery

Measure: Plasma methylation biomarker: BRCA1,2 methylation in plasma cell-free DNA

Time: At baseline, a day before surgery and 90 days after surgery

Measure: Plasma methylation biomarker: ERCC1 methylation in plasma cell-free DNA

Time: At baseline, a day before surgery and 90 days after surgery

Measure: Plasma methylation biomarker: RAD51C methylation in plasma cell-free DNA

Time: At baseline, a day before surgery and 90 days after surgery

Measure: Single-nucleotide polymorphisms: PARP-1 Val762Ala

Time: Sample will be collected once at baseline

Measure: Single-nucleotide polymorphisms: ERCC1 Asn118Asn (C/T)

Time: Sample will be collected once at baseline

Measure: Single-nucleotide polymorphisms:ERCC2 Lys751Gln (T/G)

Time: Sample will be collected once at baseline

Measure: Single-nucleotide polymorphisms: GSTP1 Ile105Val (A/G)

Time: Sample will be collected once at baseline

Measure: Single-nucleotide polymorphisms: XPD Lys751Gln (A/C, C/C)

Time: Sample will be collected once at baseline

Measure: Single-nucleotide polymorphisms: XRCC1 Arg399Gln (G/A)

Time: Sample will be collected once at baseline

Measure: Circulating tumor cells (CTCs) evaluated for DNA repair biomarkers

Time: At baseline, a day before surgery and 90 days after surgery

Measure: Circulating tumor cells (CTCs) evaluated for PD-L1

Time: At baseline, a day before surgery and 90 days after surgery


HPO Nodes


HP:0001945: Fever
Genes 374
NLRP3 PSMB4 CHD7 NABP1 PTPN22 TRNK MTHFR ND6 GALC IGH SCYL1 LIFR TREX1 BCAP31 EIF2B5 G6PD NPM1 ZBTB16 ABCC2 EPB41 CTRC DDB2 CD247 ADAMTS13 POU6F2 ND2 IFNG NTRK1 LAMA3 SCNN1A IKZF1 ND1 SLC29A3 TNFRSF1A RAG2 NLRP3 CFTR CRLF1 TP53 MALT1 CD70 ATM CACNA1S TCF4 SLC19A3 PRSS1 IL12B HLA-DPA1 JAK2 XPA CPT2 PRSS2 CFTR IL10 NAB2 ATP13A2 NCF4 REST WIPF1 NLRP3 NCF2 IGH SPTA1 SCNN1B CHEK2 H19 PTPN3 CYBC1 HTR1A BCOR LAMC2 RYR1 RAG2 TMEM165 RNASEH2C RARA DST IL6 PMM2 NCF1 CYP11B2 CD3D COX1 UNC93B1 RB1 TRAF3 MPL PSMB8 EIF2B4 IL36RN MYD88 GCH1 TH TSC1 GAA CYBA HLA-DPB1 RIPK1 NLRP12 STAT4 SPTA1 MLX TRIP13 AVP CFHR1 ELANE MPL AVPR2 P4HTM ND4 IGLL1 MST1 SLC22A4 PTS LPIN1 TRIM28 TCF3 HNRNPK IGHM CD79A PIK3R1 NOD2 MTHFR RANBP2 RYR1 LACC1 AVPR2 STAT5B STXBP2 TRNW CD79B CTLA4 NLRP3 TET2 SPTB EIF2B2 HAVCR2 HLA-DRB1 ERCC3 CYBB CD3E BCL2 DIS3L2 FOXP1 IL23R COX2 SPINK1 STAT3 GLA PRKAR1A KCNJ1 RNF168 COX3 IL7R NLRP3 TRNV FBP1 STAT2 HBB IGH GALC STX11 MEFV SLC12A3 BACH2 LPIN2 STAT3 ATP1A2 CFH CALR SLC35C1 WT1 LIFR PEX6 TRNW PRTN3 EPB42 HMGCL MEFV NOD2 HLA-B TRNS1 DCLRE1C NGLY1 IBA57 TLR4 TRNH JAK2 RAG1 ORAI1 PMP22 CYBC1 MVK AQP2 PRNP ATP1A3 CACNA1A TREX1 MEFV GATA2 ERCC2 BRCA2 OTULIN BCR ND5 IRF2BP2 IFIH1 IFNGR1 WAS RYR1 CASK NLRC4 PSAP ERCC5 ZFHX2 NLRP3 SAMHD1 COL1A1 ND1 SH3KBP1 ASAH1 SLC29A3 LACC1 TCIRG1 ND4 TNFRSF1A MEFV ACAT1 STING1 STAT4 EDA SRP54 ELP1 LAMB3 VANGL2 RMRP IRF8 IRAK1 C4A QDPR TRNQ COL1A1 KLHL7 CCND1 CCR1 UNC13D EIF2B1 UBAC2 BTK BIRC3 HNRNPK MEFV CD27 TP53 ADA RNASEH2B FAS NLRC4 CFHR3 PSMB9 BCL10 TNFAIP3 PRF1 TICAM1 ND3 VANGL2 PSTPIP1 BCL6 SLC4A1 NUMA1 PADI4 CACNA1S JAK2 HMBS TRNT1 CYP21A2 SCNN1G F5 MIF NTRK1 EIF2B3 ALPL ITK CALR ERAP1 RAB27A WDR1 HBB SPP1 MYD88 TRNL1 TLR3 ADA2 LBR IRF8 HLA-DRB1 PTPN22 TET2 STIM1 KIF1B LYST PML TRIM28 TRNF ADAR NLRP3 GYPC FIP1L1 RAG1 STAT6 TBK1 ELANE ND5 HAVCR2 HMGCL TBL1XR1 COG6 KLRC4 PTPN22 AQP2 XIAP ND6 HLA-B RNASEH2A TRNS2 IL2RG SPTB NLRP1 POLR3A HLA-DRB1 LIG4 AK2 IL10 HLA-DRB1 PRKCD MVK NKX2-1 KRT18 LRRC8A SLC12A1 IL12A-AS1 ABL1 KRT8 GPC3 ELANE LPIN2 GPR35 CYP11B2 CIITA RUNX1 BLNK TSC2 WT1 IL2RG IL7R ERCC4 ATP6 ANK1 SH2B3 IL12A CD244 LIPA RAB27A GFI1 NGF SLC11A1 CYTB POMP NFKBIL1 BTNL2 XPC HLA-B TRNL1 PRKAR1A