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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alex Shalaurov, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Inveresk Research Group, Incorporated

Authority:

United States: Federal Government

Study ID:

BIOCRYST-1777BC-101

NCT ID:

NCT00073944

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Cancer
  • 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
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • Waldenström macroglobulinemia
  • adenocarcinoma of the colon
  • adenocarcinoma of the esophagus
  • adenocarcinoma of the pancreas
  • adenocarcinoma of the rectum
  • recurrent adult brain tumor
  • recurrent adult primary liver cancer
  • recurrent colon cancer
  • recurrent esophageal cancer
  • recurrent gastric cancer
  • recurrent melanoma
  • recurrent ovarian epithelial cancer
  • recurrent pancreatic cancer
  • recurrent rectal cancer
  • adenocarcinoma of the stomach
  • adult anaplastic astrocytoma
  • adult glioblastoma
  • adult pilocytic astrocytoma
  • adult subependymoma
  • adenocarcinoma of the extrahepatic bile duct
  • recurrent extrahepatic bile duct cancer
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • de novo myelodysplastic syndromes
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult diffuse astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • T-cell large granular lymphocyte leukemia

Name

Location
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195