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Phase II Trial of Sequential Modification of Immunosuppression, Interferon Alpha, and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation.


Phase 2
15 Years
N/A
Not Enrolling
Both
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

Phase II Trial of Sequential Modification of Immunosuppression, Interferon Alpha, and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation.


OBJECTIVES: I. Evaluate the complete remission rate and survival of patients with
lymphoproliferation following organ transplantation treated with a defined sequential
approach: modification of immunosuppression, with surgery or limited radiotherapy for an
isolated site of disease; interferon alfa; and chemotherapy (ProMACE-CytaBOM;
cyclophosphamide, doxorubicin, etoposide, prednisone, cytarabine, bleomycin, vincristine,
methotrexate).

OUTLINE: All patients receive modification of immunocompetence, unless rejection is present
at outset. These patients proceed directly to interferon treatment. Group 1 (see Disease
Characteristics): Patients receive reduced doses of their current immunosuppressive therapy
for 10 days. Group 2: Patients receive reduced doses of some of their current
immunosuppressive therapy and discontinue some of the other therapy for 14 days.
Immunosuppressive therapy then resumes on day 15. Immunosuppressive therapy continues
throughout other therapy, unless otherwise noted. Some patients may then undergo surgery or
radiotherapy. Interferon therapy: Patients receive interferon alfa (IFNA) subcutaneously or
intramuscularly on days 1-28 for a maximum of 3 courses. Patients then receive maintenance
therapy with IFNA 3 days a week for 4 weeks for up to 6 courses. Chemotherapy
(ProMACE-CytaBOM): Immunosuppressive therapy is stopped on days 1-20. Patients receive
cyclophosphamide IV, doxorubicin IV, and etoposide IV over 60 minutes on day 1, oral
prednisone on days 1-14, and cytarabine IV, bleomycin IV, vincristine IV, and methotrexate
IV on day 8. Treatment is repeated every 21 days for up to 6 courses. Patients with positive
CSF cytology receive intrathecal methotrexate or cytarabine on days 1, 3, 5, 7, and 14. Some
patients may continue this therapy on day 21 , then every 3 weeks for 5 doses, or may
receive cranial irradiation. Patients are followed monthly for 1 year, every 2 months for 1
year, every 4 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 4-5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven lymphoproliferation following organ
(kidney, liver, or heart) allograft Bidimensionally measurable disease If all disease
removed at biopsy, eligible only if recurrence is bidimensionally measurable Group 1
(clinically urgent disease): Histologically proven involvement of the allograft OR
Histologically proven bone marrow involvement OR Liver involvement with hepatic
insufficiency Bilirubin greater than upper limit of normal (ULN) OR SGOT or SGPT at least
2 times ULN OR Clinical hepatic encephalopathy OR LDH at least 3 times ULN OR Systemic
sepsis OR Locally urgent lesions Tonsillar enlargement that threatens airway Superior vena
cava syndrome Bilateral hydronephrosis Postobstructive pneumonia OR Small noncleaved
lymphocytic lymphoma (i.e., adult Burkitt's lymphoma) Group 2: All other patients No CNS
disease only

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Not specified Hematopoietic:
Not specified Hepatic: See Disease Characteristics Renal: Not specified Cardiovascular:
See Disease Characteristics Pulmonary: See Disease Characteristics Other: No known AIDS,
HIV-associated complex, or positive HIV antibody No other malignancy within past 5 years,
except: Adequately treated basal or squamous cell skin cancer Adequately treated stage I
or II cancer or other noninvasive cancers Carcinoma in situ of the cervix Not pregnant or
nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon for lymphoma No prior bone
marrow transplantation Chemotherapy: No prior chemotherapy for lymphoma Endocrine therapy:
Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other:
Intra-aortic balloon pump allowed only for heart failure caused by acute rejection or
lymphomatous involvement

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Time Frame:

every 3 months while on protocol treatment

Safety Issue:

No

Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University

Authority:

United States: Federal Government

Study ID:

CDR0000064200

NCT ID:

NCT00002657

Start Date:

May 1995

Completion Date:

July 2011

Related Keywords:

  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • isolated plasmacytoma of bone
  • extramedullary plasmacytoma
  • refractory multiple myeloma
  • Waldenstrom macroglobulinemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage I small lymphocytic lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult Burkitt lymphoma
  • stage II small lymphocytic lymphoma
  • stage II grade 1 follicular lymphoma
  • stage II grade 2 follicular lymphoma
  • stage II grade 3 follicular lymphoma
  • stage II adult diffuse small cleaved cell lymphoma
  • stage II adult diffuse mixed cell lymphoma
  • stage II adult diffuse large cell lymphoma
  • stage II adult immunoblastic large cell lymphoma
  • stage II adult Burkitt lymphoma
  • stage III small lymphocytic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • stage I marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209