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Personalize Etoposide Chemotherapy Toward Small Cell Lung Cancer (SCLC) With Maximizing Effectiveness and Minimizing Risk Via Assay Single Nucleotide Polymorphisms (SNPs) of Relative Etoposide Targets, Topoisomerase II and CYP4503A4


Phase 3
22 Years
75 Years
Open (Enrolling)
Both
Small Cell Lung Cancer

Thank you

Trial Information

Personalize Etoposide Chemotherapy Toward Small Cell Lung Cancer (SCLC) With Maximizing Effectiveness and Minimizing Risk Via Assay Single Nucleotide Polymorphisms (SNPs) of Relative Etoposide Targets, Topoisomerase II and CYP4503A4


Targeted SCLC chemotherapy with VP-16 and personalized patient-specific biomarkers (SNPs)

We obtained the IND 78,420 Exemption Letter from FDA like as Drug Sponsor on 04/29/2009. In
future, any IND is not required to conduct our further relative clinical studies. // We
obtained the NCI Investigator ID 49256 from NCI like as Clinical Investigator on 01/08/2012.
// We obtained DHHS and IRB approval document: Federal-wide Assurance (FWA) for the
Protection of Human Subjects for Institutions within the United States (FWA: 00015357). So
we can develop our further relative clinical studies in USA.

Our Further Retrospect Clinical Study will use Combined Chemotherapy on ETOPOSIDE INJECTION
plus CISPLATIN INJECTION to treat Small Cell Lung Cancer (SCLC) patients, and will try to
look for the relationship between the ETOPOSIDE INJECTION therapeutic efficacy and the
Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE INJECTION
Adverse Drug Reaction and the CYP4503A4 SNP Genotyping, based on precisely sequencing drug
targets' genes.

The treatment option must be ETOPOSIDE INJECTION plus CISPLATIN INJECTION, but the the
specific SCLC patients, who had used the ETOPOSIDE INJECTION plus CISPLATIN INJECTION until
right now, have had to survive over 2 years.

According to Etoposide Injection Directions, the Etoposide efficacy target may be
Topoisomerase II and the Etoposide metabolism target should be relative to CYP4503A4. // We
hope to discover the Topoisomerase II SNP Genotypes which could be more relative to higher
therapeutic efficacies, and the CYP4503A4 SNP Genotypes which could be more relative to
lower Adverse Drug Reactions.

We will assay Single Nucleotide Polymorphisms (SNPs) of Etoposide (VP-16) drug target
(Topoisomerase II) which are relative to maximizing effectiveness, and will assay Single
Nucleotide Polymorphisms (SNPs) of Etoposide (VP-16) drug target (CYP4503A4) which are
relative to minimizing risk in the specific SCLC patients who are surviving after 2 years
used Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION, based on
precisely sequencing drug targets' genes.

In the Retrospect Stage, every patient's Combined Chemotherapy Plan must use the same
Oncology Drugs' Combination - ETOPOSIDE INJECTION plus CISPLATIN INJECTION as the patient
used at all times since 2 years ago until right now. // In the Retrospect Stage, all of SCLC
patients msut be used the same Combined Chemotherapy Plan or Oncology Drugs' Combination -
ETOPOSIDE INJECTION plus CISPLATIN INJECTION. // In the Retrospect Stage, the Combined
Chemotherapy Plan or Oncology Drugs' Combination must the ETOPOSIDE INJECTION plus CISPLATIN
INJECTION. // All of oncology drugs must be approved by USA FDA and must be sold on USA
market legally. // The dosages about all of oncology drugs must abide by their labeling in
USA. // All of Adverse Drug Reactions for all of oncology drugs in our clinical studies must
be provided most suitable and professional symptomatic treatments.

We need use the SCLC patients' tissue or humoral specimens to assay the Topoisomerase II SNP
Genotypes and the CYP4503A4 SNP Genotypes with precisely sequencing drug targets' genes in
USA.

Inclusion Criteria


- Select 400 Small-Cell Lung Cancer Patients

- Duration at least 180 days

Recruit 400 selected specific SCLC patients who are still surviving currently after at
least 2 years used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN
INJECTION. (The specific SCLC patients have been used the Combined Chemotherapy on
ETOPOSIDE INJECTION plus CISPLATIN INJECTION at all times since at least 2 years ago, and
until right now, they are still surviving.)

The inclusion criteria:

- 1.Clinical diagnosis of small cell lung cancer

- 2.Survive more than 2 years after using Combined Chemotherapy on ETOPOSIDE INJECTION
plus CISPLATIN INJECTION

- 3.Measurable disease

- 4.Adequate organ functions

- 5.Adequate performance status

- 6.Age 22 years old and over

- 7.Sign an informed consent form

- 8.Receive biopsy

- 9.Receive blood-drawing

The exclusion criteria:

- 1.Pregnancy

- 2.Breast-feeding

- 3.The patients with other serious inter-current illness or infectious diseases

- 4.Have more than one different kind of cancer in the same time

- 5.Serious Allergy to Lipids

- 6.Serious Bleed Tendency

- 7.The prohibition of the drug product

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Find Etoposide Drug Targets' SNP Genotypes which are relative to maximizing effectiveness and which are relative to minimizing risk.

Outcome Description:

Recruit 400 selected specific SCLC patients who are still surviving currently after at least 2 years used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her SCLC cell whole genome DNA with precisely sequencing. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with precisely sequencing.

Outcome Time Frame:

Duration at least 180 days

Safety Issue:

Yes

Principal Investigator

HAN XU, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medicine Invention Design Incorporation

Authority:

United States: Institutional Review Board

Study ID:

FWA00015357

NCT ID:

NCT01064466

Start Date:

July 2011

Completion Date:

July 2013

Related Keywords:

  • Small Cell Lung Cancer
  • SCLC
  • Etoposide
  • SNP
  • Topo
  • CYP
  • Genotype
  • Oncology
  • Genetics
  • Lung
  • Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Medicine Invention Design IncorporationGaithersburg, Maryland  20877