S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00016419

Collaborator

National Cancer Institute (NCI) (NIH)

130

Enrollment

Locations

Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndrome.

PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus cyclosporine in treating patients who have myelodysplastic syndrome.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes	Biological: anti-thymocyte globulin Drug: cyclosporine	Phase 2

Detailed Description

OBJECTIVES:

Determine the response in patients with myelodysplastic syndromes treated with anti-thymocyte globulin and cyclosporine.
Determine the frequency and severity of toxic effects of this regimen in these patients.
Assess the correlation between response to treatment and the in vitro assessment of T-lymphocyte subsets in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to myelodysplastic syndrome subclassification (refractory anemia [RA] vs RA with ringed sideroblasts vs RA with excess blasts).

Patients receive induction therapy comprising anti-thymocyte globulin IV over 6-12 hours on days 1-4 and oral cyclosporine twice daily on days 5-94 followed by a taper until day 124. Patients who relapse after a response of at least 60 days may receive reinduction therapy comprising oral cyclosporine twice daily on days 1-90 followed by a taper until day 120. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months, every 2 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 130 patients (53 with refractory anemia [RA], 33 with RA with ringed sideroblasts, and 44 with RA with excess blasts) will be accrued for this study within 14-22 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Jul 1, 2003

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

total response [after induction therapy is completed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Morphologically confirmed myelodysplastic syndromes (MDS)
Refractory anemia (RA)
RA with ringed sideroblasts
RA with excess blasts
Low, intermediate-1, or intermediate-2 risk by International Prognostic Scoring System criteria
MDS secondary to prior chemotherapy and/or radiotherapy for other malignant disorders allowed
Must have received prior transfusions of at least 4 units of red blood cells for anemia within the past 60 days
Must be concurrently registered on SWOG-S9910 and SWOG-9007
Ineligible for or refused participation in SWOG-S9920 (HLA-identical sibling peripheral blood stem cell transplantation)

PATIENT CHARACTERISTICS:

Age:

15 and over

Performance status:

Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other malignancy within the past 2 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 in complete remission
HIV negative
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics
Prior cytokines (e.g., interferon or interleukin), colony-stimulating factors, or epoetin alfa allowed
No prior bone marrow or stem cell transplantation
No concurrent growth factors (including epoetin alfa) except filgrastim (G-CSF) or sargramostim (GM-CSF) for neutropenia

Chemotherapy:

See Disease Characteristics
No prior remission induction chemotherapy for MDS
Prior hydroxyurea allowed

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Other:

Prior amifostine allowed
No calcium-channel blockers (diltiazem, nicardipine, or verapamil), antifungals (fluconazole, itraconazole, or ketoconazole), antibiotics (clarithromycin or erythromycin), or other drugs (bromocriptine or danazol) that would increase cyclosporine concentrations for 48 hours before, during, and for 48 hours after cyclosporine
No antibiotics (nafcillin or rifampin) or anticonvulsants (carbamazepine, phenobarbital, or phenytoin) that would decrease cyclosporine concentrations for 14 days before and during cyclosporine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
2	CCOP - Greater Phoenix	Phoenix	Arizona	United States	85006-2726
3	Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)	Phoenix	Arizona	United States	85012
4	Veterans Affairs Medical Center - Tucson	Tucson	Arizona	United States	85723
5	Arizona Cancer Center	Tucson	Arizona	United States	85724
6	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
7	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas	United States	72205
8	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
9	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
10	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California	United States	90073
11	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
12	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
13	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
14	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
15	University of California Davis Cancer Center	Sacramento	California	United States	95817
16	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California	United States	95403
17	David Grant Medical Center	Travis Air Force Base	California	United States	94535
18	University of Colorado Cancer Center	Denver	Colorado	United States	80010
19	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
20	MBCCOP - Howard University Cancer Center	Washington	District of Columbia	United States	20060
21	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342-1701
22	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia	United States	30905-5650
23	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813-2424
24	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859-5000
25	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
26	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
27	CCOP - Central Illinois	Decatur	Illinois	United States	62526
28	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois	United States	60141
29	Loyola University Medical Center	Maywood	Illinois	United States	60153-5500
30	Genesis Medical Center	Davenport	Iowa	United States	52804
31	University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7353
32	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
33	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
34	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky	United States	40502-2236
35	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
36	MBCCOP - LSU Medical Center	New Orleans	Louisiana	United States	70112
37	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
38	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana	United States	71130-3932
39	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71130
40	Boston Medical Center	Boston	Massachusetts	United States	02118
41	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts	United States	02130
42	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan	United States	48105
43	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
44	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0912
45	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
46	Veterans Affairs Medical Center - Detroit	Detroit	Michigan	United States	48201-1932
47	Henry Ford Hospital	Detroit	Michigan	United States	48202
48	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
49	CCOP - Beaumont	Royal Oak	Michigan	United States	48073-6769
50	Providence Hospital - Southfield	Southfield	Michigan	United States	48075-9975
51	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi	United States	39531-2410
52	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
53	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi	United States	39216
54	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi	United States	39534-2576
55	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
56	CCOP - Kansas City	Kansas City	Missouri	United States	64131
57	St. Louis University Health Sciences Center	Saint Louis	Missouri	United States	63110
58	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
59	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
60	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
61	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico	United States	87108-5138
62	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
63	Veterans Affairs Medical Center - Albany	Albany	New York	United States	12208
64	Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
65	University of Rochester Medical Center	Rochester	New York	United States	14642
66	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
67	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio	United States	45220-2288
68	Barrett Cancer Center	Cincinnati	Ohio	United States	45267-0501
69	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195-9001
70	CCOP - Columbus	Columbus	Ohio	United States	43206
71	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
72	CCOP - Dayton	Dayton	Ohio	United States	45429
73	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
74	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma	United States	73104
75	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97207
76	CCOP - Columbia River Program	Portland	Oregon	United States	97225
77	Oregon Cancer Institute	Portland	Oregon	United States	97239
78	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina	United States	29401-5799
79	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
80	CCOP - Greenville	Greenville	South Carolina	United States	29615
81	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
82	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
83	University of Texas Medical Branch	Galveston	Texas	United States	77555-0565
84	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
85	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7845
86	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78284
87	Veterans Affairs Medical Center - Temple	Temple	Texas	United States	76504
88	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
89	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112-5550
90	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah	United States	84148
91	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
92	Veterans Affairs Medical Center - Seattle	Seattle	Washington	United States	98108
93	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
94	Madigan Army Medical Center	Tacoma	Washington	United States	98431-5000