Spots Global Cancer Trial Database for Irinotecan and 3-AP in Treating Patients With Metastatic or Unresectable Solid Tumors

Study Description

Brief Summary: 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.

Detailed Description: PRIMARY OBJECTIVES: I. To find the maximal tolerated dose for the combination of irinotecan and Triapine® in patients with refractory solid tumors. SECONDARY OBJECTIVES: I. To find the severity and frequency of toxicity associated with this combination and to observe for and record any antitumor activity. TERTIARY OBJECTIVES: I. To evaluate the effect of Triapine®/irinotecan on the ribonucleotide reductase tyrosyl radical in vivo by Electron Paramagnetic Spectroscopy (EPR) in buccal mucosal cells, peripheral blood lymphocytes and in tumor biopsies. Formation of low molecular weight iron-Triapine® chelates will also be assessed by EPR. II. To evaluate the effect of Triapine® /irinotecan on cell cycle in vivo by measuring S-phase arrest in buccal mucosal cells. III. To evaluate the effect of Triapine® /irinotecan on MDR gene expression and polymorphisms in blood. IV. To evaluate the effect of Triapine® /irinotecan on ribonucleotide reductase R2 mRNA and Immunohistochemistry. V. To evaluate the pharmacokinetic profile of the combination. OUTLINE: This is a dose-escalation study. Patients receive irinotecan IV over 1 hour on day 1 and 3-AP (Triapine®) IV over 2 hours on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and 3-AP (Triapine®) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients are treated at that dose. Patients are followed until disease progression.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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