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BCX-1777 in Treating Patients With Refractory Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00073944
First Posted: December 11, 2003
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention Phase
Cancer Drug: forodesine hydrochloride Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2003
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
Study Chair: Alex Shalaurov, MD, PhD Inveresk Research Group, Incorporated
  More Information

ClinicalTrials.gov Identifier: NCT00073944     History of Changes
Other Study ID Numbers: BIOCRYST-1777BC-101
CDR0000341332 ( Registry Identifier: PDQ (Physician Data Query) )
CCF-5909
First Submitted: December 10, 2003
First Posted: December 11, 2003
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