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Phase I Trial of Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies


Phase 1
N/A
N/A
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndrome

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Trial Information

Phase I Trial of Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of 225Ac-HuM195 that can be administered to patients with advanced myeloid leukemias.

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Dan Douer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

02-017

NCT ID:

NCT00672165

Start Date:

July 2005

Completion Date:

July 2014

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndrome
  • MAB HUM 195 ACTINIUM-225 LABELED
  • HEMATOPOIETIC SYSTEM
  • 02-017
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021