S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00066794

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

0.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: filgrastim Biological: sargramostim Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in older patients with previously untreated acute myeloid leukemia.
Determine the frequency and severity of toxic effects of this regimen in these patients.
Determine, preliminarily, the frequency and prognostic significance of functional and phenotypic P-glycoprotein expression and cytogenetics in patients treated with this regimen.
Determine, preliminarily, the pharmacokinetic characteristics of this regimen in these patients.

OUTLINE: This is a multicenter study.

Induction therapy: Patients receive cyclosporine IV and daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7. Patients who achieve complete response (CR) after chemotherapy receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover. Patients who maintain CR after 2 courses of induction therapy proceed to consolidation therapy.
Consolidation therapy: Patients receive treatment as in induction therapy with cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5. Patients achieving CR receive an additional course of chemotherapy beginning at least 14 days after completion of the first course of cytarabine.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 25-64 patients will be accrued for this study within 13 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study Of Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

Complete remission (CR) [After induction therapy is completed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

56 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Morphologically confirmed acute myeloid leukemia (AML)
Differential diagnosis of AML based on FAB classification system
M0-M7 (No M3)
No blastic transformation of chronic myelogenous leukemia
Must be currently registered on protocols SWOG-9007 and SWOG-S9910

PATIENT CHARACTERISTICS:

Age

56 and over

Performance status

Zubrod 0-3 (for patients 56 to 60 years of age) OR
Zubrod 0-2 (for patients 61 to 70 years of age) OR
Zubrod 0-1 (for patients 71 years of age and over)

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN) unless elevated unconjugated hyperbilirubinemia is secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction
AST and/or ALT no greater than 4 times ULN

Renal

Creatinine no greater than 1.5 times ULN AND/OR
Creatinine clearance greater than 40 mL/min

Cardiovascular

Left ventricular function normal
Ejection fraction at least 50% by MUGA or echocardiogram
No unstable cardiac arrhythmias
No unstable 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, or adequately treated stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent pegfilgrastim

Chemotherapy

At least 30 days since prior low-dose cytarabine (less than 100 mg/m^2/day) for myelodysplastic syndromes and recovered
Prior hydroxyurea to control high cell counts allowed
No prior systemic chemotherapy for acute leukemia
Concurrent single-dose intrathecal chemotherapy allowed

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36652-2144
2	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724-5024
3	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California	United States	92868
4	Mercy Regional Cancer Center at Mercy Medical Center	Redding	California	United States	96049
5	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho	United States	83712
6	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois	United States	62002
7	Good Samaritan Regional Health Center	Mt. Vernon	Illinois	United States	62864
8	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
9	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
10	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
11	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
12	Southwest Medical Center	Liberal	Kansas	United States	67901
13	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
14	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
15	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
16	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
17	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
18	Stormont-Vail Cancer Center	Topeka	Kansas	United States	66604
19	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
20	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
21	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67203
22	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
23	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
24	CCOP - Wichita	Wichita	Kansas	United States	67214
25	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
26	Wesley Medical Center	Wichita	Kansas	United States	67214
27	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
28	Tulane Cancer Center	Alexandria	Louisiana	United States	71315-3198
29	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana	United States	71210
30	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
31	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
32	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
33	Bay Regional Medical Center	Bay City	Michigan	United States	48708
34	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
35	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
36	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
37	Spectrum Health Hospital - Butterworth Campus	Grand Rapids	Michigan	United States	49503
38	Metropolitan Hospital	Grand Rapids	Michigan	United States	49506
39	Holland Community Hospital	Holland	Michigan	United States	49423
40	Hackley Hospital	Muskegon	Michigan	United States	49443
41	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan	United States	48075
42	Munson Medical Center	Traverse City	Michigan	United States	49684
43	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
44	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63701
45	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Gape Girardeau	Missouri	United States	63701
46	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
47	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri	United States	63141
48	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
49	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
50	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
51	St. Vincent Healthcare	Billings	Montana	United States	59101
52	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
53	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
54	St. James Community Hospital	Butte	Montana	United States	59701
55	Big Sky Oncology	Great Falls	Montana	United States	59405
56	Great Falls Clinic	Great Falls	Montana	United States	59405
57	Sletten Regional Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
58	St. Peter's Hospital	Helena	Montana	United States	59601
59	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
60	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
61	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
62	Community Medical Center	Missoula	Montana	United States	59801
63	Clinic of Dr. Judy L. Schmidt	Missoula	Montana	United States	59804
64	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
65	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
66	Highland Hospital of Rochester	Rochester	New York	United States	14620
67	Interlakes Oncology/Hematology PC	Rochester	New York	United States	14623
68	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
69	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
70	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
71	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
72	Wilson Medical Center	Wilson	North Carolina	United States	27893-3428
73	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
74	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
75	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
76	CCOP - Columbus	Columbus	Ohio	United States	43215
77	Grant Riverside Cancer Services	Columbus	Ohio	United States	43215
78	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
79	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
80	Grady Memorial Hospital	Delaware	Ohio	United States	43015
81	Fairfield Medical Center	Lancaster	Ohio	United States	43130
82	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
83	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
84	Mercy Medical Center	Springfield	Ohio	United States	45504
85	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
86	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio	United States	43081
87	Tod Children's Hospital - Forum Health	Youngstown	Ohio	United States	44501
88	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
89	AnMed Health Cancer Center	Anderson	South Carolina	United States	29621
90	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
91	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
92	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
93	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
94	Group Health Central Hospital	Seattle	Washington	United States	98112
95	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
96	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
97	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

Southwest Oncology Group
National Cancer Institute (NCI)

Investigators

Principal Investigator: Thomas R. Chauncey, MD, PhD, VA Puget Sound Health Care System
Principal Investigator: Cheryl L. Willman, MD, University of New Mexico Cancer Center
Principal Investigator: Marilyn L. Slovak, PhD, City of Hope Comprehensive Cancer Center