Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of combining oblimersen with cytarabine and daunorubicin in treating older patients who have previously untreated acute myeloid leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may help cytarabine and daunorubicin kill more cancer cells by making them more sensitive to chemotherapy.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cytarabine; Daunorubicin; Oblimersen

Criteria

Inclusion Criteria:

• Histologically confirmed primary or secondary acute myeloid leukemia (AML)

• More than 20% bone marrow blasts

• Myelodysplastic syndromes (MDS) or a chronic myeloproliferative disorder antecedent to AML allowed

• Therapy-related AML allowed

• No acute promyelocytic leukemia

• At least 4 weeks

• Bilirubin no greater than 2 mg/dL

• ALT and AST no greater than 2 times upper limit of normal (unless directly attributable to AML)

• Creatinine no greater than 2.5 mg/dL

• Ejection fraction at least 50% by MUGA or echocardiogram

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No allergy to any of the study medications

• No other uncontrolled concurrent illness

• No serious medical or psychiatric illness that would preclude giving informed consent

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No prior therapy for primary AML except emergency leukapheresis

• No prior anthracyclines

• No prior chemotherapy for primary AML except hydroxyurea for hyperleukocytosis

• At least 3 months since prior chemotherapy for MDS or chronic myeloproliferative disorders antecedent to AML

• No other concurrent chemotherapy

• No concurrent corticosteroids as anti-emetics

• No concurrent steroids except for adrenal failure or septic shock

• No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes, tamoxifen or equivalent for breast cancer prevention or adjuvant treatment, or estrogens or progestins for gynecologic indications)

• No prior radiotherapy for primary AML except cranial radiotherapy for CNS leukostasis

• No concurrent palliative radiotherapy

• No concurrent whole brain radiotherapy

• No other concurrent investigational or commercial agents or therapies

• No concurrent cyclooxygenase-2 inhibitors