Status:
COMPLETED
Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Actinium Pharmaceuticals
Conditions:
Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The purpose of this study is to find a safe dose of actinium-225 when it is labeled to HuM195. This will be done with a "phase I trial," in which a preset schedule of doses gets more powerful for each...
Eligibility Criteria
Inclusion
- Patients must have one of the following pathologically confirmed diagnoses:
- AML in relapse,
- AML refractory to at least 2 courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy,
- CML in accelerated phase or myeloid blast crisis that has progressed after treatment with imatinib and a second generation tyrosine kinase inhibitor (e.g., dasatinib or nilotinib)
- RAEB with International Prognostic Scoring System (IPSS) score ≥ 2.5, or - CMMOL with IPSS score ≥ 2.5 refractory to or relapsed after a hypomethylating agent (e.g., azacitidine or decitabine) refractory to or relapsed after a hypomethylating agent (e.g., azacitidine or decitabine).
- Greater than 25% of bone marrow blasts must be CD33 positive.
- Patients must have a life expectancy of at least 6 weeks and a Karnofsky performance status of ≥ 60%.
- Adequate renal function as demonstrated by a serum creatinine ≤ 1.5 mg/dl, a creatinine clearance \> 60 ml/min, and \< 1 gram urinary protein/24 hours.
- Adequate hepatic function as demonstrated by a bilirubin ≤ 1.5 mg/dl (unless attributable to leukemia or Gilbert's disease) and alkaline phosphatase and AST ≤ 2.5 times the upper limit of normal.
Exclusion
- Untreated AML, regardless of prognostic features.
- Treatment with chemotherapy or biologic therapy within 3 weeks of 225Ac- HuM195 administration. Hydroxyurea is permitted but must be discontinued prior to treatment on study. Patients must have recovered from the effects of previous treatment.
- Treatment with radiation therapy within 6 weeks of 225Ac-HuM195 administration. Patients must have recovered from the effects of previous treatment.
- Active serious infections not controlled by antibiotics.
- Pregnant women or women who are breast-feeding.
- Concurrent active malignancy requiring therapy.
- Clinically significant cardiac disease (NY Heart Association Class III or IV)or pulmonary disease.
- Patients with HLA-compatible donor bone marrow who are immediate candidates for bone marrow transplantation.
- Patients who are candidates for alternative treatments of known effectiveness.
- Patients eligible for protocols of higher priority.
- Patients previously treated with any monoclonal antibody for any reason.
- Active CNS leukemia
- Other serious or life-threatening conditions deemed unacceptable by the principal investigator.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00672165
Start Date
July 1 2005
End Date
February 1 2015
Last Update
February 26 2015
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065