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Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer Clinical research trials and Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer  Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer
Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer
For Condition: small cell bone sarcoma,metastatic tumors of the Ewing's family,nonmetastatic childhood soft tissue sarcoma,localized osteosarcoma,stage 3 adult soft tissue sarcoma,stage 4A adult soft tissue sarcoma,localized tumors of the Ewing's family,desmoplastic small round-cell tumor,stage 4B adult soft tissue sarcoma,stage 3 Wilms' tumor,metastatic childhood soft tissue sarcoma,stage 4 Wilms' tumor,metastatic osteosarcoma
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
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 or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.
Details: OBJECTIVES: I. Evaluate the response rate and event-free survival of patients with peripheral neuroectodermal tumors (PNET) and Ewing's sarcoma (ES) treated with the P6 regimen (cyclophosphamide/doxorubicin/vincristine plus etoposide/ifosfamide) with surgery (if possible) followed by radiotherapy. II. Assess response to a uniform treatment regimen so as to clarify whether PNET and ES carry a different prognosis. III. Carry out comprehensive laboratory studies in order to identify biological prognostic factors and to elucidate the biological relationship between PNET and ES. PROTOCOL OUTLINE: Regimen A is given for courses 1, 2, 3, and 6 and Regimen B for courses 4, 5, and 7. Surgery is performed as feasible, and Radiotherapy is administered to all patients following chemotherapy, regardless of response. Regimen A: 3-Drug Combination Chemotherapy with Urothelial Protection. Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Vincristine, VCR, NSC-67574; with Mesna, NSC-113891. Regimen B: 2-Drug Combination Chemotherapy with Urothelial Protection. Etoposide, VP-16, NSC-141540; Ifosfamide, IFF, NSC-109724; with Mesna. Surgery. Tumor resection. Radiotherapy. Irradiation of the primary tumor site using megavoltage equipment. PROJECTED ACCRUAL: This study is conducted as two Phase II trials, one for patients with PNET and one for those with ES (it is expected that only a small number of patients with other diagnoses will be included). A maximum of 25 patients will be studied over a 3-year period in each of the two trials. If at any time on either trial more than 6 patients relapse or die of toxicity within 24 months of diagnosis, that trial will be terminated. It is anticipated that 10 patients/year from each disease category will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Patients of any age with a diagnosis confirmed by the Department of Pathology at MSKCC of one of the following entities: peripheral neuroectodermal tumors (including peripheral neuroepithelioma, Askin tumor, and adult or peripheral neuroblastoma); localized or metastatic Ewing's sarcoma; unresectable or metastatic small cell osteosarcoma; other nonrhabdomyosarcomatous soft-tissue sarcomas that are unresectable or metastatic; Wilms' tumor (metastatic or non-metastatic); desmoplastic small round-cell tumor; or other non-osteosarcomatous bone sarcomas that are unresectable or metastatic. - Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrianKushner, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000076464; MSKCC-90062,NCI-V90-0126,NYU-97-6
Study Start Date: March 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002466
Other Desmoplastic Small Round-Cell Tumor Studies:
1. Chemotherapy With or Without Trastuzumab in Treating Patients With Metastatic Osteosarcoma
2. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer
3. Neoadjuvant and Adjuvant Pamidronate With Induction and Maintenance Chemotherapy in Treating Patients With Osteosarcoma
4. Interferon alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
5. Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
Related Studies:
Other desmoplastic small round-cell tumor Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer
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