Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

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

Summary

Phase I trial to study the effectiveness of augmerosen plus fludarabine and cytarabine in treating patients who have refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Gene therapy such as augmerosen may make cancer cells more sensitive to chemotherapy drugs. Combining more than one drug with augmerosen may kill more cancer cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cytarabine; Fludarabine; Fludarabine phosphate; Lenograstim; Oblimersen; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia

• Marrow cellularity must be at least 20%

• Must have diagnostic lumbar puncture and treatment with prophylactic intrathecal methotrexate within 1 week prior to entering study

• No active CNS involvement

• CNS involvement allowed if no residual leukemic cells are detected in CSF following intrathecal chemotherapy

PATIENT CHARACTERISTICS:

• Age: 16 and over

• Performance status: ECOG 0-2

• Life expectancy: At least 4 weeks

• Bilirubin no greater than 2 times upper limit of normal(ULN)

• ALT and AST no greater than 2 times ULN

• Alkaline phosphatase no greater than 2 times ULN*

• Unless attributable to malignancy

• Creatinine no greater than 1.5 mg/dL unless attributable to malignancy

• No symptomatic congestive heart failure

• No unstable angina pectoris No or cardiac arrhythmia

• Resting cardiac ejection fraction no less than 45% unless attributable to malignancy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception before and during study

• No history of allergy to study medications

• No uncontrolled concurrent illness

• No active infection

• No serious medical or psychiatric illness that would preclude informed consent or limit survival to less than 4 weeks

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior chemotherapy except hydroxyurea

• No concurrent corticosteroids except for grade 4 toxicity unresponsive to all other agents

• At least 4 weeks since prior radiotherapy

• No other concurrent investigational or standard agents or therapies for leukemia