Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Bismuth; Cytarabine; Immunoglobulins; Lenograstim

Criteria

DISEASE CHARACTERISTICS:

• One of the following diagnoses:

• Pathologically confirmed acute myeloid leukemia (AML) meeting one of the following criteria:

• Newly diagnosed AML, over age 60, and not eligible for higher priority protocols

• Newly diagnosed AML and unable to receive anthracycline-containing or high-dose cytarabine-containing regimens

• AML in relapse

• AML refractory to two courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy

• Chronic myelogenous leukemia in accelerated phase or myeloid blast crisis

• Refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia

• More than 25% of bone marrow blasts must be CD33 positive

• Not a candidate for immediate bone marrow transplantation with a HLA-compatible donor

• No active CNS leukemia

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2 mg/dL (unless due to leukemia or Gilbert's disease)

• Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)

• AST no greater than 2.5 times ULN

Renal:

• Creatinine less than 2 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No New York Heart Association class III or IV cardiac disease

Pulmonary:

• No pulmonary disease

Other:

• No detectable antibodies to monoclonal antibody M195

• No serious active uncontrolled infection

• No other concurrent active malignancy requiring therapy

• No other serious or life-threatening conditions that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic therapy and recovered

Chemotherapy:

• See Disease Characteristics

• Prior hydroxyurea allowed if discontinued before study treatment

• At least 3 weeks since other prior chemotherapy and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• Not specified