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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma Clinical research trials and Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma clinical trial. Participants frequently obtain the most expert healthcare available for their Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma  Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
For Condition: Bone Cancer,Soft Tissue Sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and 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 II trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients who have advanced or recurrent sarcoma.
Details: OBJECTIVES: I. Determine the feasibility of sequential high-dose chemotherapy with ifosfamide and doxorubicin followed by melphalan and cisplatin, each followed by autologous peripheral blood stem cell support, in patients with high-risk or advanced sarcomas. II. Determine the toxic effects of this regimen in these patients. III. Determine response rate and disease-free and overall survival in these patients treated with this regimen. PROTOCOL OUTLINE: Beginning at least 4 weeks prior to the start of chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily until the completion of peripheral blood stem cell (PBSC) harvesting. Beginning 5 days after the start of G-CSF, PBSCs are collected over several days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Regimen A: Patients receive high-dose ifosfamide IV and doxorubicin IV continuously over 96 hours on days -8 to -4. 12.5% of PBSCs or bone marrow are reinfused on day -2 and 37.5% are reinfused on day 0. Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover. Regimen B: Beginning at least 4 weeks after day 1 of Regimen A, patients receive high-dose melphalan IV followed immediately by cisplatin IV on days -11 and -4. Patients receive G-CSF IV on days -10 to -6. 12.5% of PBSCs or bone marrow are reinfused on day -3 and the remaining 37.5% are reinfused on day 0. Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover. Patients are followed monthly for 1 year, every 3 months for 1 year, and then as needed for 3 years. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 10 Years/55 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed sarcomas in the following categories: Soft tissue sarcoma (STS); High-grade STS of the extremities; Primary extending to fascia or locally recurrent; At least 10 cm in greatest dimension or multifocal on surgical pathology; Primary site controlled by surgery and/or radiotherapy - High-grade truncal or head and neck sarcoma; At least 10 cm in greatest dimension or any size with no surgical options for clear margins; Primary site controlled by surgery and/or radiotherapy - Locally recurrent disease in CR or PR after surgery, chemotherapy, or radiotherapy - Metastatic STS in CR or PR after surgery, chemotherapy, or radiotherapy - Osteosarcoma (OS); Extremity OS after neoadjuvant chemotherapy and surgical resection provided: Less than 50% necrosis in the surgical specimen; LDH or alkaline phosphatase greater than 2 times normal at presentation; Axial OS in CR or PR after chemotherapy and/or surgery; Primary or recurrent metastatic OS in CR or PR after chemotherapy, surgery, and/or radiotherapy - Ewing's sarcoma or primitive neuroectodermal tumor; Primary site in CR or PR after chemotherapy, radiotherapy, or surgery; Rib, pelvic, or axial skeleton primary; Bulky tumor (at least 10 cm in greatest diameter); Primary or recurrent metastatic disease in CR or PR after surgery, chemotherapy, or radiotherapy - Rhabdomyosarcoma; Gross residual disease after primary treatment with surgery, chemotherapy, and radiotherapy; Primary group IV or recurrent metastatic disease in CR or PR after chemotherapy and radiotherapy with or without surgery - No brain metastasis - No histologically confirmed bone marrow metastasis; Prior metastases allowed with clearing of bone marrow at entry - No contraindication to collection of mobilized stem cells or, if needed, autologous bone marrow --Prior/Concurrent Therapy-- - More than 2 weeks since treatment to control primary or recurrent tumor - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; No more than 2 prior chemotherapy regimens (including adjuvant therapy); Prior cumulative cisplatin dose less than 400 mg/m2; Prior cumulative doxorubicin dose less than 240 mg/m2 - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; No prior radiotherapy to more than 20% of the bone marrow-containing axial skeleton; No prior radiotherapy to the left chest wall - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 10 to 55 - Performance status: Karnofsky 80-100% - Hematopoietic: Absolute neutrophil count greater than 2,000/mm3; Platelet count greater than 150,000/mm3; Hemoglobin greater than 10 g/dL - Hepatic: See Disease Characteristics; Bilirubin less than 1.5 mg/dL; AST and ALT less than 3 times normal; Hepatitis B surface antigen negative; Negative hepatitis C antigen test required in patients with hepatitis C antibody - Renal: Creatinine less than 1.4 mg/dL; Creatinine clearance greater than 75 mL/min - Cardiovascular: LVEF at least 55% by MUGA or echocardiogram; No history of significant cardiac disease - Pulmonary: FEV1 greater than 2 liters; PaO2 greater than 70 mm; Hg on room air; PaCO2 less than 42 mm Hg on room air; DLCO greater than 60% predicted - Other: No hearing loss of greater than 40 decibels; HIV negative; No organic or psychiatric CNS dysfunction that would preclude study; No other medical or psychosocial problems that would place patient at unacceptable risk; No history of other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeSomlo, Study Chair, Beckman Research Institute
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000063845; CHNMC-IRB-94072,NCI-V94-0545
Study Start Date: September 1994
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002601
Other Bone Cancer Studies:
1. Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
2. Phase II Liposomal Vincristine for Pediatric and Adolescent Patients with Relapsed Malignancies
3. Combination Chemotherapy Plus Amifostine in Treating Patients With Metastatic or Unresectable Cancer
4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
Related Studies:
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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
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