Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
NCT00001270 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2008-03-04
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 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.
Conditions
- Breast Neoplasms
- Lymphoma
- Neoplasm Metastasis
- Testicular Neoplasms
Interventions
- DRUG
-
interleukin-1
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Study Design
- Purpose
- TREATMENT
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1991-06-30
- Completion
- 2000-03-31
Countries
- United States
Study Locations
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