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

NCT00001300 | Completed Phase 3

• 2 other identifiers: 92021092-C-0210
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma

Keywords

Adjuvant Chemotherapy; Ifosfamide; Randomized Study; Soft Tissue Sarcoma

Interventions

doxorubicin DRUG

ifosfamide DRUG

mesna DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

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Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 3566372 BACKGROUND

• 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.

  PMID: 2674336 BACKGROUND

• 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.

  PMID: 3047339 BACKGROUND

MeSH Terms

Conditions

Sarcoma

Interventions

Doxorubicin; Ifosfamide; Mesna

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: June 1, 1992
• Study Completion: March 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-04

Locations

US (1)