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A Randomized Study Of The Safety And Efficacy Of Two Dose Schedules Of Gemcituzumab Ozogamicin In Patients With Intermediate-2 Or High-Risk Myelodysplastic Syndromes


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes

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Trial Information

A Randomized Study Of The Safety And Efficacy Of Two Dose Schedules Of Gemcituzumab Ozogamicin In Patients With Intermediate-2 Or High-Risk Myelodysplastic Syndromes


OBJECTIVES: I. Determine the total survival of patients with intermediate-2 or high-risk
myelodysplastic syndrome treated with gemtuzumab ozogamicin. II. Assess the quality of life
of patients treated with this drug. III. Compare two different dose schedules of this drug
in these patients. IV. Determine the safety of this drug in these patients. V. Determine the
number of patients treated with this drug that achieve complete remission, partial
remission, stable disease, major and minor hematologic improvements, or major and minor
cytogenetic responses. VI. Determine the progression-free survival, relapse-free survival,
and time to progression to acute myeloid leukemia in patients treated with this drug. VII.
Determine the number of transfusions, number of days on IV antibiotics, and the number of
days hospitalized in patients treated with this drug. VIII. Determine the possible
predictors of response in patients treated with this drug, including age, karyotype, and
multi-drug resistance efflux. IX. Determine the pharmacokinetics of this drug in these
patients. X. Correlate the results of pharmacogenomic studies to gene activation and
response to therapy in patients treated with this drug.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to age (60 and under vs over 60) and IPSS score (1.5-2.0 vs 2.5 and greater).
Patients are randomized to one of two treatment arms. Arm I: Patients receive gemtuzumab
ozogamicin IV over 2 hours on day 1. Arm II: Patients receive gemtuzumab ozogamicin IV over
2 hours on days 1 and 15. After completion of induction therapy, patients in both arms with
stable or responding disease may receive post-remission therapy comprising up to 3
additional doses of gemtuzumab ozogamicin approximately 28-42 days apart. Quality of life is
assessed at baseline, on day 29 for arm I, on day 43 for arm II, on day 127 for patients
that receive additional doses of study drug, and at 8 months for all patients. Patients who
do not respond to induction therapy are followed monthly for 8 months and then every 3
months thereafter. Patients who receive post-remission therapy are followed every 3 months.

PROJECTED ACCRUAL: Approximately 128 patients (64 per treatment arm) will be accrued for
this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed myelodysplastic syndrome (MDS)
Refractory anemia (RA) RA with ringed sideroblasts RA with excessive blasts (RAEB) RAEB in
transformation (stable disease for at least 2 months) No chromosomal abnormalities
including t(8;21), inv(16), or t(15;17) No chronic myelomonocytic leukemia proliferative
type (WBC greater than 12,000/mm3) No known CNS involvement with MDS blast progression
International Prognostic Scoring System (IPSS) score at least 1.5

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5
mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No severe cardiac disease
Pulmonary: No severe pulmonary disease Other: Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception during and for 1 year after study
HIV negative No other prior active malignancy except basal cell or squamous cell skin
cancer No uncontrolled infections

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation No prior
anti-CD33 antibodies At least 4 weeks since prior hematopoietic growth factors, epoetin
alfa, or cytokine therapy Chemotherapy: No prior chemotherapy for MDS or other malignancy
No concurrent cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior
systemic steroids except topical or inhaled steroids No concurrent systemic steroids
except topical or inhaled steroids Radiotherapy: No prior radiotherapy for MDS or other
malignancy Surgery: No prior organ transplantation Other: At least 4 weeks since prior
immunosuppressive therapy At least 4 weeks since prior investigational agents No
concurrent immunosuppressive therapy No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary J. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068805

NCT ID:

NCT00022321

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Myelodysplastic Syndromes
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • de novo myelodysplastic syndromes
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781