Status:
COMPLETED
Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Neoplasms
Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
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.
Key Trial Info
Start Date :
June 1 1991
Trial Type :
INTERVENTIONAL
End Date :
March 1 2000
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00001270
Start Date
June 1 1991
End Date
March 1 2000
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892