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BCX-1777 in Treating Patients With Refractory Cancer

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ClinicalTrials.gov Identifier: NCT00073944
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : May 30, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer Drug: forodesine hydrochloride Phase 1

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies
Study Start Date : April 2003
Actual Primary Completion Date : January 2005

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Stomach Cancer Myelodysplastic Syndromes Esophageal Cancer Ovarian Cancer Ovarian Epithelial Cancer Lymphosarcoma Cutaneous T-cell Lymphoma Glioblastoma Follicular Lymphoma Chronic Myeloid Leukemia Primary Myelofibrosis Bile Duct Cancer Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Pancreatic Cancer B-cell Lymphoma Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Mycosis Fungoides Biliary Tract Cancer Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Polycythemia Vera Essential Thrombocythemia Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Chronic Myeloproliferative Disorders Gliosarcoma Myelodysplastic/myeloproliferative Disease Anaplastic Astrocytoma Diffuse Astrocytoma Brain Tumor, Adult Burkitt Lymphoma Pilocytic Astrocytoma Anaplastic Large Cell Lymphoma Primary Liver Cancer Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Chronic Neutrophilic Leukemia Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia Subependymoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073944


Locations
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United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
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Study Chair: Alex Shalaurov, MD, PhD Inveresk Research Group, Incorporated
More Information
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ClinicalTrials.gov Identifier: NCT00073944    
Other Study ID Numbers: BIOCRYST-1777BC-101
CDR0000341332 ( Registry Identifier: PDQ (Physician Data Query) )
CCF-5909
First Posted: December 11, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: July 2004
Keywords provided by National Cancer Institute (NCI):
acute undifferentiated leukemia
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
atypical chronic myeloid leukemia, BCR-ABL1 negative
chronic eosinophilic leukemia
primary myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
essential thrombocythemia
intraocular lymphoma
myelodysplastic/myeloproliferative neoplasm, unclassifiable
polycythemia vera
previously treated myelodysplastic syndromes
primary central nervous system non-Hodgkin lymphoma
prolymphocytic leukemia
 recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent mycosis fungoides/Sezary syndrome