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
15 Years
N/A
Not Enrolling
Both
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
Both
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
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 Center | Tucson, Arizona 85724 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| MBCCOP - University of South Alabama | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
| Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Texas Tech University Health Science Center | Lubbock, Texas 79415 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
| Puget Sound Oncology Consortium | Seattle, Washington 98109 |
| Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
