Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.

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

Details

• Lead Sponsor: Genta Incorporated
• Treatments: Gemtuzumab; Oblimersen

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed CD33+ acute myeloid leukemia (AML)

• In first relapse from chemotherapy

• Complete response lasting at least 3 months before relapse

• No CNS leukemia

• No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of AML (e.g., myelodysplasia)

PATIENT CHARACTERISTICS:

Age:

• 60 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC less than 30,000/mm^3

• No bleeding or coagulation disorder except disease-related disseminated intravascular coagulation

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• PT and PTT no greater than 1.5 times upper limit of normal OR

• INR no greater than 1.3

• No history of chronic hepatitis or cirrhosis

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No uncontrolled congestive heart failure

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

Pulmonary:

• No severe pulmonary disease

Other:

• HIV negative

• No other concurrent medical disease that would preclude study entry

• No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, E. coli protein, or any product produced in E. coli

• No other concurrent malignancy

• No known human anti-human antibodies

• No uncontrolled seizure disorder

• No active uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior allogeneic or autologous stem cell transplantation

• No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195)

Chemotherapy:

• See Disease Characteristics

• At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 2 weeks since prior systemic radiotherapy

Surgery:

• At least 2 weeks since prior major surgery

• No prior organ allograft

Other:

• At least 3 weeks since prior antileukemic therapy and recovered

• No other concurrent investigational therapy

• No concurrent immunosuppressive therapy