Search / 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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Adjuvant Chemotherapy Ifosfamide Randomized Study Soft Tissue Sarcoma

Description

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.

Gender

All

Eligibility 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.

Attachments

readout_NCT00001300_2024-07-23.pdf

4.5 MB

NCT00001300_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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