Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma

This study has been completed.

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00001270

First received: November 3, 1999

Last updated: March 3, 2008

Last verified: May 1999

History of Changes

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	June 1991
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00001270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
Official Title ^ICMJE	Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
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 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.
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 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety Study Primary Purpose: Treatment
Condition ^ICMJE	Breast Neoplasms Lymphoma Neoplasm Metastasis Testicular Neoplasms
Intervention ^ICMJE	Drug: interleukin-1
Study Arm (s)	Not Provided
Publications *	Jagannath S, Dicke KA, Armitage JO, Cabanillas FF, Horwitz LJ, Vellekoop L, Zander AR, Spitzer G. High-dose cyclophosphamide, carmustine, and etoposide and autologous bone marrow transplantation for relapsed Hodgkin's disease. Ann Intern Med. 1986 Feb;104(2):163-8. Neta R, Oppenheim JJ. Cytokines in therapy of radiation injury. Blood. 1988 Sep;72(3):1093-5.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	85
Completion Date	March 2000
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00001270
Other Study ID Numbers ^ICMJE	910156, 91-C-0156
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Cancer Institute (NCI)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	May 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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