NCT00004217

S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00004217

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase II Study of Daunomycin and ARA-C Given by Continuous IV Infusion With PSC-833 for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by making them more sensitive to the drugs.

PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine in treating older patients who have newly diagnosed acute myeloid leukemia.

Eligibility

DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia (AML) No M3 AML or blastic phase chronic myelogenous leukemia Must be registered on protocols SWOG-9007 and SWOG-9910

PATIENT CHARACTERISTICS: Age: 56 and over Performance status: Zubrod 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT/SGPT no greater than 4 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance greater than 40 mL/min Cardiovascular: LVEF at least 50% by MUGA or echocardiogram No unstable cardiac arrhythmias or angina Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for acute leukemia Prior hydroxyurea to control high cell counts allowed At least 30 days since prior low dose cytarabine (less than 100 mg/m2/day) for myelodysplastic syndrome and recovered Single dose of prior or concurrent (with induction chemotherapy) intrathecal chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Disease(s) and\or Condition(s)

Leukemia

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: filgrastim
- Description: 5 μg/kg/day IV or SC
- Arm Group Labels:
- Type: BIOLOGICAL
- Name: sargramostim
- Description: 5 μg/kg/day IV or SC starting d 15
- Arm Group Labels:
- Type: DRUG
- Name: cytarabine
- Description: Ara-C continuous IV: Hours 2.5 - 170.5 before PSC-833
- Arm Group Labels:
- Type: DRUG
- Name: daunorubicin hydrochloride
- Description: continuous IV: Hours 2 - 74 before PSC-833
- Arm Group Labels:
- Type: DRUG
- Name: valspodar
- Description: 2 mg/kg load IV over 2 hrs (loading); 10 mg/kg/day Continuous hours 0 - 96
- Arm Group Labels:

Sponsor

SWOG Cancer Research Network