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Phase I Study of Continuous Infusion Schedule of (E)-2'-Deoxy-2'-(Fluoromethylene) Cytidine (Tezacitabine, FMdC) in Hematologic Malignancies


Phase 1
15 Years
N/A
Not Enrolling
Both
Hematologic Malignancies

Thank you

Trial Information

Phase I Study of Continuous Infusion Schedule of (E)-2'-Deoxy-2'-(Fluoromethylene) Cytidine (Tezacitabine, FMdC) in Hematologic Malignancies


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
dose-limiting toxicity (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 Maximum Tolerated Dose (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.

Inclusion 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
- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Description:

MTD determination made from dose level without a dose-limiting toxicity (DLT)

Safety Issue:

Yes

Principal Investigator

Stefan Faderl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID01-168

NCT ID:

NCT00061620

Start Date:

September 2001

Completion Date:

February 2004

Related Keywords:

  • Hematologic Malignancies
  • Investigational
  • Chemotherapy
  • Hematologic Malignancies
  • Nucleoside analogue
  • Neoplasms
  • Hematologic Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030