SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant
- Conditions
- LymphomaMultiple Myeloma and Plasma Cell Neoplasm
- Interventions
- Biological: bleomycin sulfateBiological: recombinant interferon alfaProcedure: conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00002657
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Reducing the amount of drugs used to prevent transplant rejection may help a person's body kill tumor cells. Giving biological therapy, such as interferon alfa, which may interfere with the growth of cancer cells, or combination chemotherapy, which uses different ways to stop tumor cells from dividing so they stop growing or die, may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of reducing immunosuppression, and giving interferon alfa and combination chemotherapy, in treating patients who have malignant tumors that develop after organ transplant.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Immumosuppression, IFN-a, ProMACE-CytaBOM bleomycin sulfate Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM recombinant interferon alfa Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM conventional surgery Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM radiation therapy Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM vincristine sulfate Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM cytarabine Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM cyclophosphamide Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM doxorubicin hydrochloride Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM etoposide Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM prednisone Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week. Immumosuppression, IFN-a, ProMACE-CytaBOM methotrexate Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week.
- Primary Outcome Measures
Name Time Method Response every 3 months while on protocol treatment
- Secondary Outcome Measures
Name Time Method overall survival every 3 months while on treatment, then every 6 months thereafter
Trial Locations
- Locations (86)
Providence Hospital - Southfield
šŗšøSouthfield, Michigan, United States
CCOP - Dayton
šŗšøKettering, Ohio, United States
Boston Medical Center
šŗšøBoston, Massachusetts, United States
CCOP - Virginia Mason Research Center
šŗšøSeattle, Washington, United States
Swedish Cancer Institute
šŗšøSeattle, Washington, United States
Veterans Affairs Medical Center - Cincinnati
šŗšøCincinnati, Ohio, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
šŗšøSan Antonio, Texas, United States
Veterans Affairs Medical Center - Tucson
šŗšøTucson, Arizona, United States
Beckman Research Institute, City of Hope
šŗšøLos Angeles, California, United States
Cancer Research Center of Hawaii
šŗšøHonolulu, Hawaii, United States
David Grant Medical Center
šŗšøTravis Air Force Base, California, United States
Arizona Cancer Center
šŗšøTucson, Arizona, United States
CCOP - Bay Area Tumor Institute
šŗšøOakland, California, United States
CCOP - Central Illinois
šŗšøDecatur, Illinois, United States
CCOP - Atlanta Regional
šŗšøAtlanta, Georgia, United States
Veterans Affairs Medical Center - Wichita
šŗšøWichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
šŗšøLexington, Kentucky, United States
CCOP - Montana Cancer Consortium
šŗšøBillings, Montana, United States
Veterans Affairs Medical Center - Jackson
šŗšøJackson, Mississippi, United States
CCOP - Wichita
šŗšøWichita, Kansas, United States
Veterans Affairs Medical Center - Shreveport
šŗšøShreveport, Louisiana, United States
Albert B. Chandler Medical Center, University of Kentucky
šŗšøLexington, Kentucky, United States
Veterans Affairs Medical Center - Biloxi
šŗšøBiloxi, Mississippi, United States
Veterans Affairs Medical Center - New Orleans
šŗšøNew Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
šŗšøShreveport, Louisiana, United States
CCOP - Metro-Minnesota
šŗšøSaint Louis Park, Minnesota, United States
Brooke Army Medical Center
šŗšøFort Sam Houston, Texas, United States
St. Louis University Health Sciences Center
šŗšøSaint Louis, Missouri, United States
Veterans Affairs Medical Center - Dayton
šŗšøDayton, Ohio, United States
Herbert Irving Comprehensive Cancer Center
šŗšøNew York, New York, United States
CCOP - Columbus
šŗšøColumbus, Ohio, United States
Vanderbilt Cancer Center
šŗšøNashville, Tennessee, United States
University of Mississippi Medical Center
šŗšøJackson, Mississippi, United States
CCOP - Greater Phoenix
šŗšøPhoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
šŗšøPhoenix, Arizona, United States
Veterans Affairs Medical Center - Denver
šŗšøDenver, Colorado, United States
University of Colorado Cancer Center
šŗšøDenver, Colorado, United States
Veterans Affairs Medical Center - Detroit
šŗšøDetroit, Michigan, United States
Henry Ford Hospital
šŗšøDetroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
šŗšøDetroit, Michigan, United States
Oklahoma Medical Research Foundation
šŗšøOklahoma City, Oklahoma, United States
CCOP - Columbia River Program
šŗšøPortland, Oregon, United States
MBCCOP - University of South Alabama
šŗšøMobile, Alabama, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
šŗšøLittle Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center
šŗšøLos Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
šŗšøLos Angeles, California, United States
Veterans Affairs Medical Center - Long Beach
šŗšøLong Beach, California, United States
Veterans Affairs Outpatient Clinic - Martinez
šŗšøMartinez, California, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
šŗšøHines, Illinois, United States
MBCCOP - LSU Medical Center
šŗšøNew Orleans, Louisiana, United States
Tulane University School of Medicine
šŗšøNew Orleans, Louisiana, United States
CCOP - Grand Rapids Clinical Oncology Program
šŗšøGrand Rapids, Michigan, United States
Keesler Medical Center - Keesler AFB
šŗšøKeesler AFB, Mississippi, United States
CCOP - St. Louis-Cape Girardeau
šŗšøSaint Louis, Missouri, United States
Veterans Affairs Medical Center - Brooklyn
šŗšøBrooklyn, New York, United States
MBCCOP - University of New Mexico HSC
šŗšøAlbuquerque, New Mexico, United States
Barrett Cancer Center, The University Hospital
šŗšøCincinnati, Ohio, United States
Cleveland Clinic Cancer Center
šŗšøCleveland, Ohio, United States
Oregon Cancer Center at Oregon Health Sciences University
šŗšøPortland, Oregon, United States
Veterans Affairs Medical Center - Oklahoma City
šŗšøOklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Portland
šŗšøPortland, Oregon, United States
CCOP - Upstate Carolina
šŗšøSpartanburg, South Carolina, United States
Veterans Affairs Medical Center - Nashville
šŗšøNashville, Tennessee, United States
University of Texas Health Science Center at San Antonio
šŗšøSan Antonio, Texas, United States
University of Texas Medical Branch
šŗšøGalveston, Texas, United States
Texas Tech University Health Science Center
šŗšøLubbock, Texas, United States
Veterans Affairs Medical Center - Temple
šŗšøTemple, Texas, United States
CCOP - Scott and White Hospital
šŗšøTemple, Texas, United States
Huntsman Cancer Institute
šŗšøSalt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
šŗšøSalt Lake City, Utah, United States
CCOP - Northwest
šŗšøTacoma, Washington, United States
Veterans Affairs Medical Center - Seattle
šŗšøSeattle, Washington, United States
Puget Sound Oncology Consortium
šŗšøSeattle, Washington, United States
University of Michigan Comprehensive Cancer Center
šŗšøAnn Arbor, Michigan, United States
University of California Davis Medical Center
šŗšøSacramento, California, United States
Veterans Affairs Medical Center - Ann Arbor
šŗšøAnn Arbor, Michigan, United States
Veterans Affairs Medical Center - Albuquerque
šŗšøAlbuquerque, New Mexico, United States
University of Arkansas for Medical Sciences
šŗšøLittle Rock, Arkansas, United States
Loyola University Medical Center
šŗšøMaywood, Illinois, United States
CCOP - Kansas City
šŗšøKansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
šŗšøSpringfield, Missouri, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
šŗšøJamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Kansas City
šŗšøKansas City, Missouri, United States
CCOP - Greenville
šŗšøGreenville, South Carolina, United States
CCOP - Santa Rosa Memorial Hospital
šŗšøSanta Rosa, California, United States
University of Kansas Medical Center
šŗšøKansas City, Kansas, United States