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
Data Collection
Neoplasms+1
+ Neoplasms by Histologic Type
+ Sarcoma
Treatment Study
Summary
Study start date: June 1, 1992
Actual date on which the first participant was enrolled.Patients with primary, high-grade soft tissue sarcoma of the extremities will undergo treatment of their primary tumor with either amputation or limb-sparing surgery and radiotherapy, and then be randomized to either observation or adjuvant treatment with doxorubicin and ifosfamide with mesna (with G-CSF) for five cycles beginning post-operatively. Local recurrence, disease-free survival and overall survival will be evaluated in this randomized two-arm trial.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Cancer Institute (NCI)
Bethesda, United StatesOpen National Cancer Institute (NCI) in Google Maps