NCT00002657

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

Official Title:

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Lymphoma

Multiple Myeloma and Plasma Cell Neoplasm

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: bleomycin sulfate
    • Description: 5 mg/m\^2
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: BIOLOGICAL
    • Name: recombinant interferon alfa
    • Description: 3.0 x 10\^6 IU/m\^2
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: 650 mg/m\^2
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: DRUG
    • Name: cytarabine
    • Description: 300 mg/m\^2
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: DRUG
    • Name: doxorubicin hydrochloride
    • Description: 25 mg/m\^2
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: DRUG
    • Name: etoposide
    • Description: 120 mg/m\^2
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: DRUG
    • Name: methotrexate
    • Description: 120 mg/m\^2
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: DRUG
    • Name: prednisone
    • Description: dose varies during initial immunosuppression. During chemotherapy, 60 mg/m\^2.
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: DRUG
    • Name: vincristine sulfate
    • Description: 1.4 mg/m\^2
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: PROCEDURE
    • Name: conventional surgery
    • Description: Simple excision, for those patients who have resectable disease after initial immunosuppression.
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
    • Type: RADIATION
    • Name: radiation therapy
    • Description: For treatment of localized disease that remains after initial immunosuppression.
    • Arm Group Labels: Immumosuppression, IFN-a, ProMACE-CytaBOM
Sponsor
  • SWOG Cancer Research Network