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Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone Clinical research trials and Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone. Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone clinical trial. Subjects often receive the most expert healthcare possible for their Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone  Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
For Condition: bone metastases,recurrent tumors of the Ewing's family,previously treated childhood rhabdomyosarcoma,recurrent childhood rhabdomyosarcoma,stage 4B adult soft tissue sarcoma,metastatic tumors of the Ewing's family,adult rhabdomyosarcoma,stage 4A adult soft tissue sarcoma,recurrent adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radioactive drugs such as holmium Ho 166 DOTMP can kill cancer cells without harming healthy cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy. PURPOSE: Phase I/II trial to study the effectiveness of holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have metastatic Ewing's sarcoma or rhabdomyosarcoma that has spread to the bone.
Details: OBJECTIVES: - Determine the dosimetry of holmium Ho 166 DOTMP in patients with metastatic Ewing's sarcoma family of tumors or rhabdomyosarcoma with bone metastases. - Provide treatment with holmium Ho 166 DOTMP for these patients. - Determine the toxicity and pharmacokinetics of this drug in these patients. - Determine the change in tumor cell content in peripheral blood and bone marrow after treatment with this drug in these patients. OUTLINE: Patients receive a trace dose of holmium Ho 166 DOTMP IV over 10 minutes on day -7 and an assigned dose over 10 minutes on day 0. Autologous peripheral blood stem cells are infused on days 7-10. Patients are followed at least weekly for 4 weeks and then monthly for 1 year or until disease progression. PROJECTED ACCRUAL: A total of 4 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed Ewing's sarcoma family of tumors or rhabdomyosarcoma with bone metastases - Refractory to conventional therapy OR - Responsive to conventional therapy with osseous metastases at diagnosis that are extensive enough to preclude concurrent radiotherapy to all sites - Soft tissue, pulmonary, and/or bone marrow metastases in addition to cortical bone allowed - Extraosseous sites of disease allowed if amenable to surgical resection or external beam radiotherapy - No patients under 10 years old with embryonal rhabdomyosarcoma - Adequate peripheral blood stem cells stored - At least 2,500,000 CD34+ cells/kg - No impending bone fracture or spinal cord compression PATIENT CHARACTERISTICS: Age: - 12 and over Performance status: - 0-2 Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 (transfusion independent) - Hemoglobin at least 10.0 g/dL (RBC transfusion allowed) Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT no greater than 2.5 times normal Renal: - Radioisotope glomerular filtration rate, iothalamate clearance, or creatinine clearance at least 60 mL/min Other: - No uncontrolled infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Recovered from prior immunotherapy - At least 3 months since prior bone marrow or peripheral blood stem cell transplantation (6 months for total body irradiation conditioning) and recovered - At least 1 week since prior cytokines - No immunomodulators during and for at least 4 weeks after study - No concurrent cytokines Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No more than 3 prior systemic chemotherapy regimens - No systemic chemotherapy during and for at least 4 weeks after study Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - See Biologic therapy - Recovered from prior radiotherapy - No prior maximum tolerable radiotherapy (greater than 30 Gy) to the spinal cord - No prior therapeutic doses of bone-seeking radiopharmaceutical (e.g., samarium Sa 153 lexidronam pentasodium EDTMP) - No radiotherapy during and for at least 4 weeks after study - Local radiotherapy to any tumor site allowed provided at least 1 evaluable lesion is untreated Surgery: - See Disease Characteristics - No surgical resection of all bone metastases evaluable by PET during and for 1 month after study Other: - At least 4 weeks since prior bisphosphonates
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DouglasHawkins, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000068159; CHMC-S-6007,NCI-G00-1842,FHCRC-1474.00
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006234
Other Stage 4b Adult Soft Tissue Sarcoma Studies:
1. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors
2. Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
3. Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors
4. Chemotherapy in Treating Patients With Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor
5. Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor
Related Studies:
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Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
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