A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
60 Years
N/A
Both
Leukemia
Trial Information
A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
OBJECTIVES:
Primary
- Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the
complete remission rate, in older patients with relapsed acute myeloid leukemia.
- Determine the toxicity and pharmacokinetics of this regimen in these patients.
Secondary
- Correlate clinical response with laboratory studies of drug susceptibility in patients
treated with this regimen.
OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17.
Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab
ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease
progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate
- More than 20% blasts by morphologic criteria
- Relapsed disease ≥ 3 months after prior complete remission
- Blasts CD33-positive by flow cytometry
- No primary hematologic disorder that preceded initial presentation with AML
- No documented secondary AML related to prior chemotherapy or toxin exposure
- No acute promyelocytic leukemia (FAB M3)
- Not a candidate for transplant therapy
- No active CNS leukemia
PATIENT CHARACTERISTICS:
Age
- 60 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC ≤ 30,000/mm^3 (hydroxyurea allowed)
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 mg/dL
Other
- HIV negative
- No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not planning hematopoietic stem cell transplantation immediately after study therapy
Chemotherapy
- See Disease Characteristics
- See Hematopoietic
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 1 month since prior investigational agents
- No other concurrent anticancer therapy
- No administration of any of the following for 24 hours after cyclosporine
administration:
- Diltiazem
- Verapamil
- Erythromycin
- Clarithromycin
- Metoclopramide
- Phenytoin
- Rifampin
- Phenobarbital
- Aminoglycosides
- Amphotericin B
- Vancomycin
- Cimetidine
- Ranitidine
- Trimethoprim/sulfamethoxazole
- Ketoconazole
- Fluconazole
- Itraconazole
- Voriconazole
- Carbamazepine
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy in terms of complete remission rate
Safety Issue:
No
Principal Investigator
Stephen H. Petersdorf, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1820.00
NCT ID:
NCT00089050
Start Date:
May 2004
Completion Date:
March 2006
Related Keywords:
- Leukemia
- recurrent adult acute myeloid leukemia
- adult acute minimally differentiated myeloid leukemia (M0)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myelomonocytic leukemia (M4)
- adult acute monoblastic leukemia (M5a)
- adult acute monocytic leukemia (M5b)
- adult erythroleukemia (M6a)
- adult pure erythroid leukemia (M6b)
- adult acute megakaryoblastic leukemia (M7)
- adult acute basophilic leukemia
- adult acute eosinophilic leukemia
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
