An Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP) in Cancer Patients Using a Single Daily Dose for Five Days
triapine
Treatment Study
Summary
Study start date: May 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the effects of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) in patients with solid tumors by evaluating the safety and tolerability, maximum tolerated dose (MTD) and recommended dose for Phase II studies, pharmacokinetics, and tumor response. OUTLINE: This is a dose escalation study. Patients receive 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) IV over 2 hours on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of 3-AP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for 4 weeks or until recovered. PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor that has failed 1 or more conventional treatments or is unlikely to respond to currently available therapies No active CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL AST and ALT no greater than 3 times upper limit of normal (ULN) Alkaline phosphate no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 3 months No symptomatic coronary artery disease or heart block No uncontrolled congestive heart failure Pulmonary: No moderate or severe pulmonary dysfunction Other: Not pregnant or nursing Negative pregnancy test Fertile women must use effective contraception Body weight greater than 50 kg No active infection No mental deficits and/or psychiatric disorders that would preclude study No other life-threatening illness No bleeding disorder (except occult blood from gastrointestinal cancer) PRIOR CONCURRENT THERAPY: Biologic therapy: Prior growth factor treatment allowed if blood counts normal Chemotherapy: At least 3 weeks since prior chemotherapy and recovered At least 6 weeks since prior nitrosoureas or mitomycin and recovered Prior hydroxyurea allowed and recovered Endocrine therapy: At least 2 weeks since prior hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to greater than 30% of the bone marrow Surgery: At least 2 weeks since any prior major surgery Other: At least 4 weeks since other prior investigational agents and recovered No other concurrent investigational agents without consent of sponsor
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Arizona Clinical Research Center
Tucson, United StatesOpen Arizona Clinical Research Center in Google MapsYale Comprehensive Cancer Center
New Haven, United States