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A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer Clinical research trials and A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer. A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer clinical trial. Human subjects often get the best healthcare available for their A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer  A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer
A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer
For Condition: Breast Neoplasm,Neoplasm Metastasis
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Efforts to cure metastatic and high-risk breast cancer have increasingly focused on the application of dose intensive chemotherapy. To date, the use of dose intensive and high dose chemotherapy has not significantly changed the survival for the majority of high risk and metastatic patients. The optimal schedule and combination of agents to improve the results of high dose chemotherapy is not known. This study will pilot a combination of chemotherapy agents for the treatment of metastatic and high-risk breast cancer. Specifically, patients will receive multiple cycles of a dose intensive combination of Paclitaxel and Cyclophosphamide both for the mobilization of peripheral blood progenitor cells and with therapeutic intent. Patients will subsequently receive high dose Melphalan and Etoposide followed by the infusion of peripheral blood progenitor cells and granulocyte colony stimulating factor (G-CSF). The primary endpoints of this study will be the toxicities and feasibility of this chemotherapy combination. In addition, patients participating in this study will provide the opportunity to examine several important secondary agendas including (1) the effects of high dose chemotherapy on T-cell immunity (2) the regeneration pathways of T-cells in adult patients after high dose chemotherapy (3) methods of CD34+ selection and T-cell depletion of peripheral progenitor cell collections; this pilot study will serve as a prelude to gene marking studies of CD34+ cells for the definitive examination of T-cell repopulation pathways (4) the effects of CD34+ selection on tumor contamination of peripheral progenitor cell collections. To examine the regeneration pathways of hematopoietic stem cells and T-cells, an infusion of [6,6- (2)H(2)] or [U-(13)C(9)]-glucose prior to leukocyte harvest will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. [6,6-(2)H(2)] or [U-(13)C(9)]-glucose are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and are chemically identical to glucose, with no adverse side effects other than those known for glucose. The patients treated in this study will also be eligible for entrance into other protocols of the Transplantation Therapy Section that are examining strategies of manipulating T-cell regeneration in adults after intensive chemotherapy.
Details: Efforts to cure metastatic and high-risk breast cancer have increasingly focused on the application of dose intensive chemotherapy. To date, the use of dose intensive and high dose chemotherapy has not significantly changed the survival for the majority of high risk and metastatic patients. The optimal schedule and combination of agents to improve the results of high dose chemotherapy is not known. This study will pilot a combination of chemotherapy agents for the treatment of metastatic and high-risk breast cancer. Specifically, patients will receive multiple cycles of a dose intensive combination of Paclitaxel and Cyclophosphamide both for the mobilization of peripheral blood progenitor cells and with therapeutic intent. Patients will subsequently receive high dose Melphalan and Etoposide followed by the infusion of peripheral blood progenitor cells and granulocyte colony stimulating factor (G-CSF). The primary endpoints of this study will be the toxicities and feasibility of this chemotherapy combination. In addition, patients participating in this study will provide the opportunity to examine several important secondary agendas including (1) the effects of high dose chemotherapy on T-cell immunity (2) the regeneration pathways of T-cells in adult patients after high dose chemotherapy (3) methods of CD34+ selection and T-cell depletion of peripheral progenitor cell collections; this pilot study will serve as a prelude to gene marking studies of CD34+ cells for the definitive examination of T-cell repopulation pathways (4) the effects of CD34+ selection on tumor contamination of peripheral progenitor cell collections. To examine the regeneration pathways of hematopoietic stem cells and T-cells, an infusion of [6,6- (2)H(2)] or [U-(13)C(9)]-glucose prior to leukocyte harvest will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. [6,6-(2)H(2)] or [U-(13)C(9)]-glucose are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and are chemically identical to glucose, with no adverse side effects other than those known for glucose. The patients treated in this study will also be eligible for entrance into other protocols of the Transplantation Therapy Section that are examining strategies of manipulating T-cell regeneration in adults after intensive chemotherapy.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Age greater than or equal to 18 years. All patients must have a histologically confirmed diagnosis of Infiltrating Breast Carcinoma stage III B. IPatients with no clinical inflammatory signs but with tumor invasion of dermal lymphatic on histology are eligible. Patients with metastatic disease and Inflammatory Breast Carcinoma are not eligible. All pathologic material must be reviewed and confirmed by the Department of Pathology of the Clinical Center prior to treatment. Patients may be untreated or may have received prior induction chemotherapy outside the NCI. They may have received chemotherapy either before (neo-adjuvant setting) or after local surgery (adjuvant setting) Karnofsky performance status of greater than 70% (ECOG 0 or 1). Ejection fraction by MUGA or 2-D echocardiogram of greater than 45%. Creatinine clearance of greater than 60 cc/mm. AST and ALT less than 3X upper limit of normal. Bilirubin less than 1.5 (except in cases of Gilbert's disease). ANC greater than 1000/mm(3). Platelet count greater than 90,000/mm(3). DLCO greater than 50%. No history of medical or psychiatric disease which would preclude safe treatment in the View of the principal investigator. No history of abnormal bleeding tendency or predisposition to repeated infections. Patients must be able to give informed consent. EXCLUSION CRITERIA: Patients with Inflammatory Breast Cancer buth with metastatic disease. Any patient may be excluded from this study at the discretion of the principal investigator if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk. Any patient with a need for chronic steroids or anticoagulation will be ineligible. Any patient testing positive for HIV (AIDS) or hepatitis B or C will be ineligible. Any female patient known or found to be pregnant will be considered ineligible. Patients of childbearing potential unwilling to practice contraception will be ineligible. Any patient with an active second malignancy (excluding treated skin cancers or carcinoma in situ) will be ineligible. Any patient with a history of diabetes mellitus will be excluded from receiving [6,6- (2)H(2)] or [U-(13)C(9)]-glucose infusions.
Total Enrollment: 120
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 960104; 96-C-0104
Study Start Date: July 12, 1996
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001507
Other Breast Neoplasm Studies:
1. Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial
2. Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein
3. A Phase I Study of Oral COL-3 (NSC-683551), a Matrix Metalloproteinase Inhibitor, in Patients with Refractory Metastatic Cancer
4. Direct Injection of Alcohol for the Treatment of Spinal Tumors
5. Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
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A Pilot Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Metastatic and High Risk Breast Cancer
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