Irinotecan and 3-AP in Treating Patients With Metastatic or Unresectable Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy such as irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may help irinotecan kill more tumor cells by making them more sensitive to the drug.

Key facts

Study ID

NCT00084877

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2004-03-01

Last updated by the study team

2013-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
• Patients must not have previously received irinotecan
• Patients must not have received radiation to > 25% of bone marrow
• ECOG performance status =< 2
• Life expectancy of greater than 12 weeks
• Leukocytes >= 3,000/μl
• Absolute neutrophil count >= 1,500/μl
• Platelets >= 100,000/μl
• Total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
• Creatinine =< 1.5 mg/dl OR creatinine clearance >= 50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• Patients must have measurable or evaluable disease
• Patients must have baseline screening for G6PD (glucose-6-phosphate dehydrogenase) deficiency; G6PD must be no lower than the lower limit of normal prior to starting study treatment; patients who are above the upper limit of normal may enroll in the trial
• The effects of Triapine® on the developing human fetus are unknown; for this reason and because heterocyclic carboxaldehyde thiosemicarbazones as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document
• Patients must have a baseline screening test for UGT1A1; the UGT1A1 cannot be the 7/7 genotype; patients who have any other combinations (6/6, 6/7, 5/7, etc.) may enroll in the trial

You may not qualify if…

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
• Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients with grade 1 adverse events from prior therapies are eligible at the investigator's discretion
• Patients may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Triapine® or other agents used in study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because Triapine® is a heterocyclic carboxaldehyde thiosemicarbazone with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Triapine®, breastfeeding should be discontinued if the mother is treated with Triapine®; these potential risks may also apply to other agents used in this study
• Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Triapine® or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
• Patients with known G6PD deficiency are excluded
• Patients with a history of myocardial infarction or severe pulmonary disease requiring oxygen are excluded
• Because of the potential for enzyme-inducing anticonvulsant agents (EIACAs) to alter the metabolism and pharmacokinetics of irinotecan, patients who are taking EIACAs are excluded
• Metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry; also the patient must not be undergoing acute steroid therapy or taper
• Patients with UGT1A1 7/7 genotype are excluded

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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