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

NCT00061620 | Completed Phase 1

• 1 other identifier: ID01-168
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematologic Malignancies

Keywords

Investigational; Chemotherapy; Hematologic Malignancies; Nucleoside analogue

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

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

Study Arms (1)

Tezacitabine

EXPERIMENTAL

Tezacitabine as a bolus infusion daily x 5

Drug: Tezacitabine (FMdC)

Interventions

Tezacitabine (FMdC) DRUG

7.5 mg/m2 bolus infusion daily x 5

Also known as: FMdC, (E)-2'-Deoxy-2'-(Fluoromethylene) Cytidine

Tezacitabine

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Chiron Corporation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson Cancer Center's website

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

tezacitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Stefan Faderl, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2003
• First Posted: June 2, 2003
• Study Start: September 6, 2001
• Primary Completion: February 12, 2004
• Study Completion: February 12, 2004
• Last Updated: November 1, 2018

Record last verified: 2018-10

Locations

US (1)