Combination Chemotherapy in Treating Patients With Sarcoma

NCT00662233 | Completed Early Phase 1 DMC

• 5 other identifiers: CDR0000582271P30CA015083919110542-910791
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients with sarcoma.

Conditions

Ovarian Cancer; Sarcoma

Keywords

alveolar childhood rhabdomyosarcoma; previously treated childhood rhabdomyosarcoma; previously untreated childhood rhabdomyosarcoma; recurrent childhood rhabdomyosarcoma; nonmetastatic childhood soft tissue sarcoma; recurrent childhood soft tissue sarcoma; childhood desmoplastic small round cell tumor; ovarian sarcoma; stage II uterine sarcoma; stage III uterine sarcoma; embryonal childhood rhabdomyosarcoma

Outcome Measures

Primary Outcomes (4)

• Efficacy in terms of long-term disease-free survival

• Clinical response of the tumors

• Pathologic response of the tumors

• Long term disease-free survival

Interventions

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

vincristine sulfate DRUG

adjuvant therapy PROCEDURE

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

brachytherapy RADIATION

intraoperative radiation therapy RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of any of the following: * High-grade nonmetastatic, nonrhabdomyosarcomatous soft tissue sarcomas (excluding undifferentiated sarcoma and Ewing sarcoma) * Small round cell sarcomas (excluding primitive neuroectodermal tumors of soft tissue) (closed to accrual) * Undifferentiated sarcomas (closed to accrual) * Rhabdomyosarcomas (excluding non-parameningeal head tumors, vaginal or stage I paratesticular) (closed to accrual) * All alveolar rhabdomyosarcomas (closed to accrual) * No evidence distant metastatic disease (i.e., lung, bone, bone marrow) * Local or regional nodal disease allowed * No spindle cell tumors of bone * Primary lesions do not have to be resectable PATIENT CHARACTERISTICS: * Creatinine ≤1.5 mg/dL OR creatinine clearance \> 60 mL/min/ * AST/ALT \< 2 times upper limit of normal (ULN) * Total bilirubin \< 2 times ULN * LVEF ≥ 45% * No prior history of cancer * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: * Patients who have undergone radiation therapy after initial surgery are eligible but must have evaluation for metastatic disease within 2 weeks of starting chemotherapy * No prior chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Sarcoma; Desmoplastic Small Round Cell Tumor

Interventions

Cyclophosphamide; Doxorubicin; Etoposide; Ifosfamide; Vincristine; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Brachytherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Carola A. S. Arndt, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 21, 2008
• Study Start: October 1, 1991
• Primary Completion: October 21, 2013
• Study Completion: October 21, 2013
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)