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Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma

This study has been completed.

Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003970
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup.

PURPOSE: Phase I trial to study genetic testing and the effectiveness of irinotecan in treating patients who have solid tumors and lymphoma.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
Procedure: mutation analysis
Phase I

MedlinePlus related topics:   Cancer    Fungal Infections    Hodgkin's Disease    Intestinal Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma   

Drug Information available for:   Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I Clinical Trial to Investigate the Correlation Between UGT1A1 Genotype and Irinotecan (CPT-11) Pharmacokinetics and Toxicity in Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 1999

Detailed Description:

OBJECTIVES:

  • Classify patients with solid tumors or lymphoma according to UGT1A1 promoter (TATA box) and coding region (Gly71Arg) mutation, and CYP3A4 promoter (G to A) polymorphisms.
  • Identify UGT1A1 enzyme glucuronidator and irinotecan oxidizer phenotypes in these patients and determine the correlation between the two metabolic reactions in vivo.
  • Determine the relationship between UGT1A1 genotype (promoter and/or coding region mutation) and CYP3A4 promoter genotype vs gastrointestinal or bone marrow toxicity, and pharmacokinetics of irinotecan in these patients.
  • Determine the pharmacokinetics of irinotecan in these patients.

OUTLINE: Patients are genotyped for UGT1A1 enzyme and classified as "Gilbert's" (7/7), "heterozygotes" (6/7), and "homozygotes for allele 6" (6/6). The DNA is analyzed for the UGT1A1 coding region mutation (Gly71Arg) and CYP3A4 promoter polymorphism. Patients are also examined for glucuronidator ratio of SN-38, the active metabolite of irinotecan, and classified as "low/slow" (very low or zero SN-38G/SN-38 ratio), "intermediate" (less than 50% normal ratio), or "normal".

Patients receive irinotecan IV over 90 minutes once every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 20 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven solid tumor or lymphoma

    • Responded to irinotecan OR no existing curative therapy
  • No leukemia
  • Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3500/mm^3
  • Absolute neutrophil count at least 1500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • SGOT/SGPT less than 5 times upper limit of normal (unless due to disease)

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No inflammatory bowel disease requiring therapy
  • No chronic diarrhea syndrome or paralytic ileus

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 2 weeks since prior colony stimulating factor
  • At least 4 weeks since prior biologic therapy
  • No concurrent biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow
  • No concurrent palliative radiotherapy

Surgery:

  • No prior transplant

Other:

  • No concurrent substrates of UGT1A1 enzyme
  • No concurrent inducers or inhibitors of UGT1A1 enzyme activity
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003970

Locations
United States, Illinois
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637

Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)

Investigators
Study Chair:     Mark J. Ratain, MD     University of Chicago    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067173, UCCRC-T98-0039, UCCRC-L97-0270, NCI-T98-0039
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003970
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent adult Hodgkin lymphoma  
stage III cutaneous T-cell non-Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
small intestine lymphoma  
unspecified adult solid tumor, protocol specific  
stage III grade 1 follicular lymphoma  
stage III grade 2 follicular lymphoma  
stage III grade 3 follicular lymphoma  
stage III adult diffuse small cleaved cell lymphoma  
stage III adult diffuse mixed cell lymphoma  
stage III adult diffuse large cell lymphoma  
stage III adult immunoblastic large cell lymphoma  
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Study placed in the following topic categories:
Sezary syndrome
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Duodenal Neoplasms
Mycoses
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Camptothecin
B-cell lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Hodgkin's disease
Gastrointestinal Diseases
Cutaneous T-cell lymphoma
Irinotecan
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome
Mycosis Fungoides
Lymphoma, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Jejunal Diseases
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Ileal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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