BCX-1777 in Treating Patients With Refractory Cancer

BioCryst Pharmaceuticals

Overview

RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Cancer

Interventions

forodesine hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Data from ClinicalTrials.gov

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