BCX-1777 in Treating Patients With Refractory Cancer - Full Text View

Sponsored by:	BioCryst Pharmaceuticals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00073944

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 I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Pancrelipase Ultrase Forodesine Forodesine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000341332, BIOCRYST-1777BC-101, CCF-5909
Study First Received:	December 10, 2003
Last Updated:	November 16, 2008
ClinicalTrials.gov Identifier:	NCT00073944
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

acute undifferentiated leukemia
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
atypical chronic myeloid leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
essential thrombocythemia
intraocular lymphoma
myelodysplastic/myeloproliferative disease, unclassifiable
polycythemia vera
previously treated myelodysplastic syndromes
primary central nervous system 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

Study placed in the following topic categories:

Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Preleukemia
Leukemia, Prolymphocytic
Hemorrhagic thrombocythemia
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Rectal cancer
Myelodysplastic syndromes
Essential thrombocytosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Astrocytoma
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Acute myelogenous leukemia
Leukemia, Myeloid
Brain Neoplasms
Waldenstrom Macroglobulinemia
B-cell lymphomas
Anaplastic large cell lymphoma
Esophageal Diseases
Lymphoma, Non-Hodgkin
Hairy cell leukemia
Lymphoma, Follicular
Sezary Syndrome
Lymphoma, B-Cell

ClinicalTrials.gov processed this record on January 15, 2009