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Combination Chemotherapy in Treating Patients With Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662233
First Posted: April 21, 2008
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
  Purpose

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.


Condition Intervention
Ovarian Cancer Sarcoma Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: brachytherapy Radiation: intraoperative radiation therapy Radiation: radiation therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Pilot Study for Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Efficacy in terms of long-term disease-free survival
  • Clinical response of the tumors
  • Pathologic response of the tumors
  • Long term disease-free survival

Enrollment: 28
Actual Study Start Date: October 1991
Study Completion Date: October 21, 2013
Primary Completion Date: October 21, 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To evaluate the efficacy, in terms of clinical response, pathologic response, and long-term disease-free survival, of a multidrug chemotherapy regimen patients with spindle cell or small round cell sarcoma.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive vincristine IV, cyclophosphamide IV over 1 hour and doxorubicin hydrochloride IV over 48 hours on day 1 in week 0. Patients continue to receive vincristine IV once weekly in weeks 1 and 2. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 3. Treatment repeats every 6 weeks for 2 courses.
  • Local control: After completing induction therapy, patients are reevaluated for local control therapy. Some patients may undergo surgery and/or radiotherapy (e.g., brachytherapy, intraoperative radiotherapy, external beam therapy). Patients who undergo surgery begin consolidation therapy 2 weeks after completing surgery. Some patients undergo radiotherapy 5 days a week for 5½ weeks beginning at week 12 and/or after surgery (weeks 15-16).
  • Consolidation therapy: Patients receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in weeks 12 and 18*. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 15. Patients are reevaluated for local control therapy at week 21.

NOTE: *Patients undergoing radiotherapy do not receive doxorubicin hydrochloride in week 18 or week 24.

  • Maintenance therapy: Patient receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in week 24. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 21. Treatment repeats every 6 weeks for 3 courses. In week 36, patients receive vincristine, doxorubicin hydrochloride and cyclophosphamide OR etoposide and ifosfamide as before. In week 39 patients receive etoposide and ifosfamide as before.

After completion of treatment, patients are followed periodically for at least 5 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662233


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Carola A. S. Arndt, MD Mayo Clinic
  More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00662233     History of Changes
Other Study ID Numbers: CDR0000582271
P30CA015083 ( U.S. NIH Grant/Contract )
919110 ( Other Identifier: Mayo Clinic Cancer Center )
542-91 ( Other Identifier: Mayo Clinic IRB )
0791 ( Registry Identifier: COGUM )
First Submitted: April 18, 2008
First Posted: April 21, 2008
Last Update Posted: May 25, 2017
Last Verified: April 2016

Keywords provided by Mayo Clinic:
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

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Ifosfamide
Liposomal doxorubicin
Doxorubicin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators