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A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias


Phase 1
1 Year
21 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias


OBJECTIVES:

Primary

- Determine the maximum tolerated dose and recommended phase II dose of temozolomide in
pediatric patients with refractory or recurrent leukemia.

- Determine the toxic effects of this drug in these patients.

- Determine the pharmacokinetics of this drug in these patients.

Secondary

- Determine the antitumor activity of this drug in these patients.

- Determine the biologic activity and mechanism(s) of resistance to this drug in these
patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days
for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18-24
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed leukemia of any of the following types:

- Acute lymphoblastic leukemia

- Acute myeloid leukemia

- Chronic myelogenous leukemia in blast crisis

- Refractory or recurrent disease

- Immunophenotypic confirmation of disease at initial diagnosis or recurrence

- More than 25% blasts in the bone marrow (M3)

- Active extramedullary disease allowed except for leptomeningeal disease

- No known curative therapy or therapy proven to prolong survival with an acceptable
quality of life

- No active CNS disease

PATIENT CHARACTERISTICS:

Age

- 1 to 21

Performance status

- Karnofsky 50-100% (for patients > 10 years of age)

- Lansky 50-100% (for patients ≤ 10 years of age)

Life expectancy

- Not specified

Hematopoietic

- WBC < 30,000/mm^3 (hydroxyurea or leukapheresis allowed at the discretion of the
principal investigator)

- Platelet count ≥ 20,000/mm^3 (platelet transfusions allowed)

- Hemoglobin ≥ 8.0 g/dL (red blood cell transfusions allowed)

Hepatic

- ALT ≤ 5 times upper limit of normal (ULN)

- Albumin ≥ 2 g/dL

- Bilirubin ≤ 1.5 times ULN

Renal

- Creatinine normal for age OR

- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min/1.73 m^2

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 7 days since prior biologic therapy, including immunotherapy

- At least 3 months since prior stem cell transplantation

- No evidence of active graft-vs-host disease

- No concurrent biologic therapy

- No concurrent immunotherapy

Chemotherapy

- Recovered from prior chemotherapy

- At least 6 weeks since prior nitrosoureas

- Prior therapy with hydroxyurea allowed for up to 24 hours before initiation of study
drug

- No other concurrent chemotherapy

Endocrine therapy

- Concurrent hydrocortisone or other corticosteroids allowed as premedications prior to
blood product transfusions in patients with prior severe allergic reactions

Radiotherapy

- Recovered from prior radiotherapy

- No concurrent radiotherapy

Surgery

- Not specified

Other

- No other concurrent anticancer agents

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose and recommended phase II dose

Safety Issue:

Yes

Principal Investigator

Terzah M. Horton, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000362059

NCT ID:

NCT00083070

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • relapsing chronic myelogenous leukemia
  • childhood acute promyelocytic leukemia (M3)
  • blastic phase chronic myelogenous leukemia
  • Leukemia

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Fairview University Medical Center - University CampusMinneapolis, Minnesota  55455
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399