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Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Clinical research trials and Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors. Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors  Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors
Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors
For Condition: Brain Tumor,Testicular Cancer,Bone Cancer,childhood liver cancer
Status: No longer recruiting
Sponsor(s): Johns Hopkins Oncology Center ,
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to evaluate the effectiveness of peripheral stem cell transplantation and chemotherapy in treating patients with malignant solid tumors.
Details: OBJECTIVES: I. Determine whether autologous transplantation of mobilized CD34+ peripheral blood stem cells (PBSC) can provide complete hematologic reconstitution after myeloablative chemotherapy comprising etoposide (VP-16) and carboplatin (CBDCA) in patients with metastatic or recurrent rhabdomyosarcoma, neuroblastoma, Ewing's sarcoma/primitive neuroectodermal tumor, germ cell tumors, childhood brain tumors, or hepatoblastoma. II. Determine the frequency and yield of CD34+ PBSC and granulocyte-macrophage colony-forming units (GM-CFU) that are mobilized, harvested, and purified after a single priming course of high-dose cyclophosphamide (CTX) followed by filgrastim (G-CSF). III. Correlate the number of CD34+ cells and GM-CFU in the autologous PBSC graft with time to engraftment of white blood cells, neutrophils, and platelets in these patients. IV. Determine the optimal day of PBSC harvest after a single priming course of high-dose CTX and G-CSF in these patients. V. Determine whether CD34+ PBSC rescue and daily post-transplant G-CSF decrease the time to hematopoietic recovery after high-dose VP-16 and CBDCA compared to historical results achieved in similar patients rescued with bone marrow. VI. Compare the tumor cell content of marrow, mobilized blood, and purified CD34+ PBSC graft preparations. VII. Determine the optimal timing of PBSC mobilization and harvest in relation to extent of prior chemotherapy in these patients. VIII. Determine the feasibility of a single leukapheresis for PBSC harvest in children. IX. Determine the toxic effects of this regimen in these patients. X. Determine the antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of cyclophoshamide. Mobilization/harvest: Patients receive cyclophosphamide IV over 90 minutes on day 0 and filgrastim (G-CSF) subcutaneously or IV over 30 minutes on days 2-15 or until blood counts recover. Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells on day 15. Bone marrow is also harvested in case insufficient PBSC are harvested. Preparative regimen/transplantation: Patients receive carboplatin IV over 1 hour and etoposide IV continuously on days -6 to -4. Cyclophosphamide is administered IV over 1 hour on days -3 and -2 or IV continuously on days -3 and -2, -4 to -2, -5 to -2, or -6 to -2. PBSC or bone marrow is reinfused on day 0. Cohorts of 3-10 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 20% of patients experience dose-limiting toxicity. At least 6 additional patients receive cyclophosphamide at the MTD. PROJECTED ACCRUAL: A minimum of 36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /35 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven malignant solid tumor that is metastatic or has failed at least first-line therapy, e.g.: Rhabdomyosarcoma; Neuroblastoma; Ewing's sarcoma/primitive neuroectodermal tumor; Germ cell tumors; Childhood brain tumors; Hepatoblastoma - Ineligible for higher priority protocols --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: Under 36 at transplantation - Performance status: Karnofsky 60-100% - Life expectancy: At least 8 weeks - Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Platelet count at least 75,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; Liver function tests no greater than 2 times normal OR No active hepatitis on liver biopsy; No hepatitis B infection - Renal: Creatinine no greater than 1.5 mg/dL OR GFR (preferably measured) greater than 60% of normal - Cardiovascular: Left ventricular ejection fraction at least 45%; No active congestive heart failure; No active arrhythmia - Pulmonary: Age 8 and under: Clinically normal pulmonary function; Over age 8: FEV1 and FVC at least 50% predicted; Arterial blood gases normal and DLCO at least 50% if spirograms difficult to interpret due to poor patient effort, recent surgery, or pulmonary tumor involvement - Other: No mucositis or mucosal infection prior to myeloablative chemotherapy; HIV negative; Not pregnant
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AllenChen, Study Chair, Johns Hopkins Oncology Center
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
United States
Additional Information:
Study ID Numbers: CDR0000064263; NCI-V95-0688,JHOC-9512
Study Start Date: May 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007813
Other Childhood Liver Cancer Studies:
1. Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors
2. Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors
3. High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
4. Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
5. Genetic Study in Patients Receiving Treatment for Hodgkin's Disease or Childhood Brain Tumor
Related Studies:
Other childhood liver cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors
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