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Clinical Trial · NCT00014495
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
Overview
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in treating patients who have advanced myeloid cancer.
Sponsor
Memorial Sloan Kettering Cancer Center
Phase
Phase 1/2
Contacts
Joseph G. Jurcic, MD (STUDY_CHAIR)
ClinicalTrials.gov
NCT00014495Drug / Compound
M195
Isotope(s):
BISMUTH-213
Radioisotope: Bi-213
Theranostic Role: Therapeutic
T1/2 (Half-Life): 45.6 minutes
Decay Mode: Beta
Energy: 1.42–1.44 MeV
Range: 50 to 80 µm
Decay Daughters: Polonium-213, Lead-209, Bismuth-209
Status: Clinical Trials
Target(s):
- CD33
Ligand Class: Antibodies
Eligibility
Inclusion
- Chronic myelogenous leukemia in accelerated phase or myeloid blast crisis
- At least 3 weeks since prior biologic therapy and recoveredChemotherapy:
- Negative pregnancy test
- AST no greater than 2.5 times ULNRenal:
- Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)
- Bilirubin no greater than 2 mg/dL (unless due to leukemia or Gilbert's disease)
- AML refractory to two courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy
- Refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia
- More than 25% of bone marrow blasts must be CD33 positive
- Prior hydroxyurea allowed if discontinued before study treatment
- At least 3 weeks since prior radiotherapy and recoveredSurgery:
- One of the following diagnoses:
- At least 3 weeks since other prior chemotherapy and recoveredEndocrine therapy:
- Creatinine clearance greater than 60 mL/minCardiovascular:
- Karnofsky 60-100%Life expectancy:
- Fertile patients must use effective contraceptionBiologic therapy:
- Pathologically confirmed acute myeloid leukemia (AML) meeting one of the following criteria:
- Creatinine less than 2 mg/dL OR
- Newly diagnosed AML and unable to receive anthracycline-containing or high-dose cytarabine-containing regimens
- AML in relapse
Exclusion
- No New York Heart Association class III or IV cardiac diseasePulmonary:
- Not a candidate for immediate bone marrow transplantation with a HLA-compatible donor
- No detectable antibodies to monoclonal antibody M195
- Not specified
- Not specifiedHematopoietic:
- Not specifiedRadiotherapy:
- Not pregnant or nursing
- No pulmonary diseaseOther:
- No other concurrent active malignancy requiring therapy
- No other serious or life-threatening conditions that would preclude study
- Not specifiedHepatic:
- No serious active uncontrolled infection
- Not specifiedPerformance status:
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