Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies
Data Collection
Treatment Study
Summary
Study start date: April 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies. * Determine the safety and dose-limiting toxicity of this drug in these patients. Secondary * Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients. * Determine the oral bioavailability of this drug in these patients. * Determine, preliminarily, the antitumor activity of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. * Courses 1 and 2: Patients receive oral BCX-1777 on days 1 and 15\* and BCX-1777 IV over 30 minutes on days 8\* and 22\*. * Course 3: Beginning approximately 6 days\* after the completion of courses 1 and 2, patients receive BCX-1777 IV over 30 minutes once daily on days 1-5 and 8-12 (total of 10 doses). NOTE: \*+/- 1 day Patients with stable disease or better and no dose-limiting toxicity (DLT) may receive an additional 10-dose treatment course (as in course 3) after a 10- to 16-day drug-free interval. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BCX-1777 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 DLT. Patients are followed at 14 and 30 days. PROJECTED ACCRUAL: A total of 3-24 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 diagnosis of 1 of the following: * Hematologic malignancy that is refractory to at least 1 prior curative treatment * Non-hematologic tumor that is refractory to at least 2 prior therapies, with or without measurable disease, including the following: * Gastrointestinal adenocarcinoma of 1 of the following sites: * Pancreatic * Biliary * Gastric * Colorectal * Esophageal * Melanoma * Ovarian cancer * Astrocytoma brain tumor * Not immediately eligible for any other treatment that would be potentially curative or life-prolonging, in the opinion of the investigator * Patients who may be candidates for future bone marrow transplantation are eligible * No brain metastases (other than astrocytomas) * No clinically significant pleural effusion * No complete tumor obstruction (e.g., bronchus, ureter, or bowel) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * WBC at least 3,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count greater than 50,000/mm\^3 * Hematocrit stable without the need for transfusion (epoetin alfa support allowed) Hepatic * Bilirubin less than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome) * SGOT and SGPT less than 2 times ULN * No active hepatitis B or C Renal * Creatinine clearance at least 50 mL/min Cardiovascular * No American Heart Association class III or IV cardiac disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active systemic infection requiring IV antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Concurrent corticosteroids allowed provided the patient is on a stable regimen Radiotherapy * Not specified Surgery * Not specified Other * Recovered from prior therapy * No grade 2-4 toxicity * More than 3 weeks since prior antineoplastic and/or investigational therapy * No other concurrent systemic antineoplastic or investigational therapy
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 1 location