Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with
 autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid
 cancers. The initial goal of this study was to define the toxicity of interleukin-1
 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated
 with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second
 cohort of 18 patients also received G-CSF and engraftment was further shortened in some
 subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF.
 Accrual will continue to further define the toxicity and efficacy of this regimen.
This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with
 autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid
 cancers. The initial goal of this study was to define the toxicity of interleukin-1
 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated
 with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second
 cohort of 18 patients also received G-CSF and engraftment was further shortened in some
 subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF.
 Accrual will continue to further define the toxicity and efficacy of this regimen.
A history of pathologically documented (clinical documentation may be acceptable at
 relapse):

 Breast cancer: metastatic or locally advanced (Stage III/IV) with stable minimal (less than
 or equal to 2 cm) residual disease after 2 cycles of appropriate combination chemotherapy
 may start BMT.

 Non-Hodgkin's lymphomas: all stages of relapsed or induction failure (FSC, FM, FL, DSC, DL,
 DM, DIDL, IBL, LBL, SNC) after appropriate chemotherapy.

 Hodgkin's lymphomas: all stages of chemotherapy induction failures, first relapse less than
 or equal to 1 year from chemotherapy induced remission, first relapse greater than 1 year
 from chemotherapy induced remission if there is extranodal involvement at relapse, greater
 than or equal to 2 relapses (one may be after radiation) following appropriate combination
 chemotherapy, or relapse at any time from radiation therapy with stage IIB, IIIB, IV A/B.

 Testicular cancer: all stages of relapsed or induction failure following appropriate
 combination chemotherapy.

 No evidence of central nervous system cancer.

 Patients must be between 18 and 65 years old.

 Normal cardiac function: no history of angina pectoris, myocardial infarction, congestive
 heart failure or ejection fraction less than 40 percent.

 Creatinine clearance greater than or equal to 45 cc/min/m(2), bilirubin less than or equal
 to 1.5, SGOT less than or equal to 2x normal, and normal PT, PTT and calcium.

 Negative HIV serology and hepatitis B surface antigen.

 Adequate pulmonary function (PFTs are only obtained in patients with clinical evidence of
 pulmonary dysfunction): DLCO greater than 50 percent, compensated for Hgb, FEV 1 greater
 than 55 percent and PO2 greater than 60.

 Negative bilateral bone marrow biopsies prior to bone marrow harvest.

 No evidence of metastatic disease to the pelvis on plain film or bone scan.

 Karnofsky performance status greater than or equal to 70 and a life expectancy greater than
 or equal to 60 days.

 No evidence of pregnancy or risk of pregnancy at the time of transplantation in women.

 Ability to give informed consent.

 Good psychiatric and medical risk.