BCX-1777 in Treating Patients With Refr… | Clinical Trial

Key information

Conditions

Cancer Adenocarcinoma Adenocarcinoma Of Esophagus Adnexal Diseases Astrocytoma Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Brain Diseases Brain Neoplasms Burkitt Lymphoma Carcinoma Carcinoma, Hepatocellular Carcinoma, Ovarian Epithelial Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Chronic Disease Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Ependymoma Epstein-Barr Virus Infections Esophageal Diseases Esophageal Neoplasms Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glioblastoma Glioma Glioma, Subependymal Gliosarcoma Gonadal Disorders Head and Neck Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Intraocular Lymphoma Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Liver Diseases Liver Neoplasms Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Melanoma Multiple Myeloma Mycosis Fungoides Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Polycythemia Vera Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Rectal Diseases Rectal Neoplasms Sezary Syndrome Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

forodesine hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

BioCryst Pharmaceuticals

Industry

Registry information

Official study title

Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies

Important dates

Study start: 2003
Primary completion: 2005
First posted: Dec 11, 2003
Registry last updated: May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed