Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: filgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: mesna Drug: vincristine sulfate Procedure: conventional surgery Radiation: brachytherapy Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | PHASE II STUDY OF NEOADJUVANT VINCRISTINE, IFOSFAMIDE, DOXORUBICIN, AND G-CSF IN CHILDREN WITH ADVANCED STAGE NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMAS |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 1996 |
OBJECTIVES: I. Assess the response to vincristine/ifosfamide/doxorubicin (VID) with granulocyte colony-stimulating factor support in children with newly diagnosed, inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas. II. Estimate the 2-year and event-free survival rates in children treated with VID plus radiotherapy and/or surgery. III. Establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies.
OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 Mesna Mercaptoethane sulfonate, NSC-113891 VCR Vincristine, NSC-67574 VID VCR/IFF/DOX Induction: 3-Drug Combination Chemotherapy. VID. Local Control: Surgery and/or Radiotherapy plus 3-Drug Combination Chemotherapy. Excision of the primary tumor and pulmonary metastases; and/or irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV (electrons or iridium-192 implant allowed for boost); plus VID. Continuation: 3-Drug Combination Chemotherapy. VID.
PROJECTED ACCRUAL: A total of 40 patients will be entered over 2.7 years if there are at least 7 responses in the first 20 patients.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Biopsy proven non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) Evaluable residual tumor after initial biopsy or excision required Registration required within 42 days of definitive diagnosis Grade II/III, unresectable or metastatic disease The following histologies exclude: Angiofibroma of the nasopharynx Mesothelioma Desmoid tumor Peripheral neuroepithelioma Desmoplastic small cell tumor Rhabdomyosarcoma Extraosseous Ewing's sarcoma Undifferentiated sarcoma Kaposi's sarcoma Grade 1 NRSTS, including: Angiomatoid malignant fibrous histiocytoma Dermatofibrosarcoma protuberans Myxoid and well-differentiated liposarcoma Well-differentiated and infantile hemangiopericytoma Well-differentiated malignant peripheral nerve sheath tumor
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine normal for age No hydronephrosis Cardiovascular: Shortening fraction greater than 28% Other: No HIV infection Not pregnant or nursing Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior nephrectomy (surgical correction of hydronephrosis allowed)
Contacts and Locations| United States, Kansas | |
| Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| MBCCOP - LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| United States, Texas | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | |
| Lackland Air Force Base, Texas, United States, 78236-5300 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Virginia | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| Puerto Rico | |
| University of Puerto Rico School of Medicine Medical Sciences Campus | |
| San Juan, Puerto Rico, 00936-5067 | |
| Switzerland | |
| Clinique de Pediatrie | |
| Geneva, Switzerland, 1211 | |
| Study Chair: | Alberto S. Pappo, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002804 History of Changes |
| Other Study ID Numbers: | CDR0000064905, POG-9553 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
nonmetastatic childhood soft tissue sarcoma metastatic childhood soft tissue sarcoma |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Isophosphamide mustard Ifosfamide Vincristine Lenograstim Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013