- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001300
A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma
Randomized study. All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A.
Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost.
Arm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF,
NSC-614629; and Mesna, NSC-113891.
Arm II: Observation. No adjuvant chemotherapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically proven AR and ESFT which includes: Classical, atypical and extraosseous Ewing's sarcoma, primitive peripheral neuroectodermal tumors, peripheral neuroepithelioma, primitive sarcoma of bone, and ectomesenchymoma.
Confirmed presence of tumor-specific infusion protein by documented RT-PCR which corresponds to one of the tumor specific peptides available for vaccination.
Measurable tumor.
No prior or current CNS metastases.
PRIOR/CONCURRENT THERAPY:
Arm A patients:
May be enrolled on the protocol for the first phase in the absence of RT PCR documentation of a tumor-specific fusion protein which corresponds to one of the tumor-specific peptides available for vaccination. However, RT PCR documentation at the time of tumor recurrence must occur prior to administration of immunotherapy. At time of initial tumor diagnosis, prior to any cytoreductive therapy.
Arm B patients:
Tumor recurrence occurring during or after receiving at least first line cytoreductive therapy for ESFT and AR. No more than two post-recurrence salvage regimens unless peripheral CD4+T cell number is greater than 400 cells per millimeter cubed.
At least 6 weeks since any treatments and recovered from all acute toxic effects from time in which immunotherapy will be started for this study.
No concurrent estrogen therapy during immunotherapy section of study.
PATIENT CHARACTERISTICS:
Age: 2-25 (at time of initial diagnosis of alveolar rhabdomyosarcoma).
Weight: Greater than 15 kg (at time of apheresis).
Performance status: ECOG 0-2.
Life expectancy: At least 8 weeks.
Hematopoietic:
ANC greater than 100,000/mm3.
Hemoglobin greater than 9.0 g/dL.
Platelet count greater than 50,000/mm3.
Hepatic:
Bilirubin less than 2.0 mg/dL (unless related to involvement by tumor).
Transaminases less than 3 times normal (unless related to involvement by tumor).
Renal:
Creatinine less than 1.5 mg/dL or creatinine clearance greater than 60 mL/min.
Cardiovascular:
No major disorder of cardiovascular system.
Cardiac ejection fraction greater than 40%.
Pulmonary:
No major disorder of pulmonary system.
Other:
Not pregnant or nursing.
HIV negative.
Hepatitis B or C negative.
No patients requiring daily oral corticosteroid therapy.
If allergic to eggs, egg products, or thimerosal, or have a history of Guillain-Barre syndrome, ineligible to receive influenza vaccine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lawrence W Jr, Donegan WL, Natarajan N, Mettlin C, Beart R, Winchester D. Adult soft tissue sarcomas. A pattern of care survey of the American College of Surgeons. Ann Surg. 1987 Apr;205(4):349-59. doi: 10.1097/00000658-198704000-00003.
- Alvegard TA, Sigurdsson H, Mouridsen H, Solheim O, Unsgaard B, Ringborg U, Dahl O, Nordentoft AM, Blomqvist C, Rydholm A, et al. Adjuvant chemotherapy with doxorubicin in high-grade soft tissue sarcoma: a randomized trial of the Scandinavian Sarcoma Group. J Clin Oncol. 1989 Oct;7(10):1504-13. doi: 10.1200/JCO.1989.7.10.1504.
- Chang AE, Kinsella T, Glatstein E, Baker AR, Sindelar WF, Lotze MT, Danforth DN Jr, Sugarbaker PH, Lack EE, Steinberg SM, et al. Adjuvant chemotherapy for patients with high-grade soft-tissue sarcomas of the extremity. J Clin Oncol. 1988 Sep;6(9):1491-500. doi: 10.1200/JCO.1988.6.9.1491.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Ifosfamide
- Doxorubicin
Other Study ID Numbers
- 920210
- 92-C-0210
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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