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SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant

Information source: Southwest Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Intervention: bleomycin sulfate (Biological); recombinant interferon alfa (Biological); cyclophosphamide (Drug); cytarabine (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); methotrexate (Drug); prednisone (Drug); vincristine sulfate (Drug); conventional surgery (Procedure); radiation therapy (Radiation)

Phase: Phase 2

Status: Completed

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Lode J. Swinnen, MD, Study Chair, Affiliation: Loyola University
Leo I. Gordon, MD, Study Chair, Affiliation: Robert H. Lurie Cancer Center

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.

Clinical Details

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

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

Primary outcome: Response

Secondary outcome: overall survival

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.

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

MBCCOP - University of South Alabama, Mobile, Alabama 36688, United States

CCOP - Greater Phoenix, Phoenix, Arizona 85006-2726, United States

Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix, Arizona 85012, United States

Arizona Cancer Center, Tucson, Arizona 85724, United States

Veterans Affairs Medical Center - Tucson, Tucson, Arizona 85723, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas 72205, United States

Veterans Affairs Medical Center - Long Beach, Long Beach, California 90822, United States

Beckman Research Institute, City of Hope, Los Angeles, California 91010, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, California 90033-0800, United States

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California 94553, United States

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

University of California Davis Medical Center, Sacramento, California 95817, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

David Grant Medical Center, Travis Air Force Base, California 94535, United States

University of Colorado Cancer Center, Denver, Colorado 80262, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois 60141, United States

Loyola University Medical Center, Maywood, Illinois 60153, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky 40511-1093, United States

MBCCOP - LSU Medical Center, New Orleans, Louisiana 70112, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, United States

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana 70112, United States

Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana 71130-3932, United States

Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana 71130, United States

Boston Medical Center, Boston, Massachusetts 02118, United States

Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts 02130, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0752, United States

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan 48105, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Veterans Affairs Medical Center - Detroit, Detroit, Michigan 48201-1932, United States

CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan 49503, United States

Providence Hospital - Southfield, Southfield, Michigan 48075-9975, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi 39531-2410, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi 39216, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri 64128, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri 63110-0250, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico 87108-5138, United States

Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York 11209, United States

Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States

Barrett Cancer Center, The University Hospital, Cincinnati, Ohio 45219, United States

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio 45220-2288, United States

Cleveland Clinic Cancer Center, Cleveland, Ohio 44195, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

CCOP - Dayton, Kettering, Ohio 45429, United States

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 73104, United States

Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma 73104, United States

CCOP - Columbia River Program, Portland, Oregon 97213, United States

Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon 97201-3098, United States

Veterans Affairs Medical Center - Portland, Portland, Oregon 97207, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Vanderbilt Cancer Center, Nashville, Tennessee 37232-6838, United States

Veterans Affairs Medical Center - Nashville, Nashville, Tennessee 37212, United States

Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States

University of Texas Medical Branch, Galveston, Texas 77555-1329, United States

Texas Tech University Health Science Center, Lubbock, Texas 79423, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas 78284, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Veterans Affairs Medical Center - Temple, Temple, Texas 76504, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah 84148, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Puget Sound Oncology Consortium, Seattle, Washington 98109, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

Veterans Affairs Medical Center - Seattle, Seattle, Washington 98108, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 1995
Last updated: January 22, 2013

Page last updated: August 20, 2015

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