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A Dose Finding Study of the Safety of Gemtuzumab Ozogamicin Combined With Conventional Chemotherapy for Patients With Relapsed or Refractory Acute Myeloid Leukemia


Phase 1
N/A
21 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

A Dose Finding Study of the Safety of Gemtuzumab Ozogamicin Combined With Conventional Chemotherapy for Patients With Relapsed or Refractory Acute Myeloid Leukemia


OBJECTIVES:

- Determine the safety and maximum tolerated dose of gemtuzumab ozogamicin in combination
with conventional chemotherapy in patients with relapsed or refractory acute myeloid
leukemia or myelodysplastic syndromes.

- Determine the efficacy of this regimen in these patients.

- Correlate the likelihood of leukemic blast cells to undergo apoptosis in vitro with the
efficacy of this regimen in these patients.

- Correlate drug resistance as manifested by dye efflux or multiple drug resistance-1
expression by leukemic blast cells with the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study of gemtuzumab ozogamicin. Patients are
assigned by cohort to 1 of 2 treatment regimens.

- Regimen A: Patients receive cytarabine IV over 2 hours every 12 hours on days 1-4,
mitoxantrone IV over 1 hour on days 3-6, and gemtuzumab ozogamicin IV over 2 hours on
day 7.

- Regimen B: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 2, 8,
and 9, asparaginase intramuscularly on days 2 and 9, and gemtuzumab ozogamicin IV over
2 hours on day 3.

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

Patients are followed monthly for 6 months, every 2 months for 6 months, every 6 months for
2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 1.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of primary acute myeloid leukemia (AML) or myelodysplastic syndromes

- Relapsed (remission duration less than 1 year) OR

- Failed induction (failed to achieve an initial complete response)

- Patients with AML as a second malignant neoplasm allowed provided no other prior
therapy for AML

- M2 or M3 bone marrow aspirate at time of study entry

- No Fanconi's anemia

- No known CNS leukemia

PATIENT CHARACTERISTICS:

Age:

- 21 and under

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 1.5 times normal

- AST or ALT less than 2.5 times upper limit of normal

- No history of veno-occlusive disease of the liver defined as weight increase of more
than 5% over baseline and serum bilirubin greater than 5 mg/dL within 20 days after
receipt of chemotherapy

Renal:

- Creatinine no greater than 1.5 times normal OR

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70
mL/min OR

- Equivalent GFR by institutional normal range

Cardiovascular:

- Shortening fraction more than 27% by echocardiogram or normal for institution OR

- Ejection fraction more than 50% by MUGA

Other:

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 180 days since prior hematopoietic stem cell transplantation

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard Aplenc, MD, MSCE

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Philadelphia

Authority:

United States: Federal Government

Study ID:

CDR0000069145

NCT ID:

NCT00028899

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent childhood acute myeloid leukemia
  • secondary acute myeloid leukemia
  • previously treated myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Newark Beth Israel Medical CenterNewark, New Jersey  07112
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Children's Hospital of AustinAustin, Texas  78701
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Fairview University Medical Center - University CampusMinneapolis, Minnesota  55455
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Children's Hospital and Health Center - San DiegoSan Diego, California  92123-4282
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
C.S. Mott Children's Hospital at University of MichiganAnn Arbor, Michigan  48109-0238
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Cancer CenterDenver, Colorado  80218
Columbus Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital of Minnesota - MinneapolisMinneapolis, Minnesota  55404