NCT00002657

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	bleomycin sulfate	5 mg/m\^2
BIOLOGICAL	recombinant interferon alfa	3.0 x 10\^6 IU/m\^2
DRUG	cyclophosphamide	650 mg/m\^2
DRUG	cytarabine	300 mg/m\^2
DRUG	doxorubicin hydrochloride	25 mg/m\^2
DRUG	etoposide	120 mg/m\^2
DRUG	methotrexate	120 mg/m\^2
DRUG	prednisone	dose varies during initial immunosuppression. During chemotherapy, 60 mg/m\^2.
DRUG	vincristine sulfate	1.4 mg/m\^2
PROCEDURE	conventional surgery	Simple excision, for those patients who have resectable disease after initial immunosuppression.
RADIATION	radiation therapy	For treatment of localized disease that remains after initial immunosuppression.

Timeline

• Start date: 1995-05-01
• Primary completion: 2003-11-01
• Completion: 2011-07-01
• First posted: 2004-06-22
• Last updated: 2013-01-24

Locations

86 sites across 1 country: United States