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Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies

This study has been terminated.

Sponsors and Collaborators: M.D. Anderson Cancer Center
Chiron Corporation
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00061620
  Purpose

The goal of this clinical research study is to find the highest dose of Tezacitabine (FMdC) which can be safely given as a continuous infusion by vein to patients with hematologic malignancies. The general safety and effectiveness of this drug will also be studied.


Condition Intervention Phase
Hematologic Malignancies
Drug: Tezacitabine (FMdC)
Phase I

MedlinePlus related topics:   Cancer   

Drug Information available for:   MDL 101731    Tezacitabine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase I Study of Continuous Infusion Schedule of (E)-2'-Deoxy-2'-(Fluoromethylene) Cytidine (Tezacitabine, FMdC) in Hematologic Malignancies

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:   30
Study Start Date:   September 2001

Detailed Description:

Patients with leukemias that have relapsed from previous therapies have a low cure rate. Hence the need to discover new antileukemic agents. Tezacitabine is a nucleoside analogue with equivalent or even superior activity when compared with ara-C in leukemic cell lines. It has shown significant antitumor activity in vitro and in vivo tumor models. Several phase I studies with various dosing schedules have been conducted in solid tumors where the DLT is mainly myelosuppression, usually a favorable feature for development of leukemia. In a phase I study in hematological malignancies, we used Tezacitabine as a bolus infusion daily x 5. The DLT consisted of grade 3 CNS toxicities and mucositis in 3/6 patients. The study is ongoing and we are currently evaluating a dose level of 7.5 mg/m2 as possible MTD. However, in view of the fact that tezacitabine is a cell cycle specific agent with a short terminal plasma half-life of 2 to 6 hours, a continuous infusion dosing schedule may enhance the activity and reduce the incidence of adverse effects of tezacitabine.

  Eligibility
Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • Patient with relapsed/refractory acute leukemias (AML, ALL, high-grade myelodysplastic syndromes, CMML in transformation with >/= 10% peripheral blood/bone marrow blasts, CML in blast crisis), or patients with relapsed/refractory CLL and an absolute neutrophil count of >/= 1,000/ml and platelet count of >/= 75,000/ml.
  • Signed informed consent indicating that patients are aware of the investigational nature of this study, and in keeping with the policies of this hospital. The only acceptable consent form is attached at the end of this protocol.
  • Age >/= 15 years.
  • ECOG performance status </= 2.
  • No severe, concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for study entry.
  • Pregnant and/or lactating females are not eligible.
  • Normal organ function (serum bilirubin £ 2 mg/dL, serum creatinine £ 2 mg/dL). Patients with renal or liver dysfunction due to organ leukemic involvement may be eligible after discussion with the principle investigator.
  • Patients must be off of all previous chemotherapy, immunotherapy, or radiotherapy for at least 2 weeks prior to entering this study, and must have recovered from all toxic effects, unless life-threatening increases in tumor burden occur.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061620

Locations
United States, Texas
M.D. Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
Chiron Corporation
  More Information


M.D. Anderson Cancer Center's website  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   ID01-168
First Received:   May 30, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00061620
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Investigational  
Chemotherapy  
Hematologic Malignancies  
Nucleoside analogue  

Study placed in the following topic categories:
Hematologic Neoplasms
Hematologic Diseases
2'-deoxy-2'-(fluoromethylene)cytidine

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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