Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
NCT ID: NCT00003970
Last Updated: 2013-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
1999-01-31
Brief Summary
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Detailed Description
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I. 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.
II. Identify UGT1A1 enzyme glucuronidator and irinotecan oxidizer phenotypes in these patients and determine the correlation between the two metabolic reactions in vivo.
III. 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.
IV. 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (irinotecan hydrochloride)
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.
irinotecan hydrochloride
Given IV
Interventions
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irinotecan hydrochloride
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Responded to irinotecan OR no existing curative therapy
* No leukemia
* Measurable or evaluable disease
* Performance status - Karnofsky 70-100%
* WBC at least 3500/mm\^3
* Absolute neutrophil count at least 1500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin normal
* SGOT/SGPT less than 5 times upper limit of normal (unless due to disease)
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No inflammatory bowel disease requiring therapy
* No chronic diarrhea syndrome or paralytic ileus
* At least 2 weeks since prior colony stimulating factor
* At least 4 weeks since prior biologic therapy
* No concurrent biologic therapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No other concurrent chemotherapy
* At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow
* No concurrent palliative radiotherapy
* No prior transplant
* No concurrent substrates of UGT1A1 enzyme
* No concurrent inducers or inhibitors of UGT1A1 enzyme activity
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Mark Ratain
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Comprehensive Cancer Center
Locations
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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9531
Identifier Type: -
Identifier Source: secondary_id
CDR0000067173
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02304
Identifier Type: -
Identifier Source: org_study_id
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