|
Feasibility Study of Interleukin 1-Alpha with Ifosfamide, CBDCA, and Etoposide with Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Feasibility Study of Interleukin 1-Alpha with Ifosfamide, CBDCA, and Etoposide with Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Feasibility Study of Interleukin 1-Alpha with Ifosfamide, CBDCA, and Etoposide with Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma Clinical research trials and Feasibility Study of Interleukin 1-Alpha with Ifosfamide, CBDCA, and Etoposide with Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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 Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Feasibility Study of Interleukin 1-Alpha with Ifosfamide, CBDCA, and Etoposide with Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma clinical trial. Test subjects typically receive the most expert healthcare available for their Feasibility Study of Interleukin 1-Alpha with Ifosfamide, CBDCA, and Etoposide with Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > 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
Feasibility Study of Interleukin 1-Alpha with Ifosfamide, CBDCA, and Etoposide with Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
For Condition: Breast Neoplasms,Lymphoma,Neoplasm Metastasis,Testicular Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 85
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 910156; 91-C-0156
Study Start Date: June 17, 1991
Record last reviewed: May 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001270
Other Testicular Neoplasms Studies:
1. Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
2. Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
3. Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors
4. Direct Injection of Alcohol for the Treatment of Spinal Tumors
5. Phase I Study of PEG-Paclitaxel In Patients with Advanced Solid Tumors & Lymphomas
Related Studies:
Other Testicular Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Feasibility Study of Interleukin 1-Alpha with Ifosfamide, CBDCA, and Etoposide with Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma
|
|
|
|
|
|
|
|
