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Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: February 10, 2004   Last Updated: July 7, 2009   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077285
  Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy (first-line therapy) works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma.


Condition Intervention Phase
Sarcoma
Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Pilot Phase II Trial Of Irinotecan Plus Carboplatin, And Irinotecan Maintenance Therapy (High-Risk Patients Only), Integrated Into The Upfront Therapy Of Newly Diagnosed Patients With Intermediate - And High-Risk Rhabdomyosarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Safety and feasibility [ Designated as safety issue: Yes ]
  • Rate of local control [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of in vitro measurements of angiogenesis with clinical features (extent of disease), response to therapy, and outcome [ Designated as safety issue: No ]
  • Efficacy in terms of improved outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: October 2003
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed rhabdomyosarcoma (RMS), undifferentiated sarcoma, or ectomesenchymoma, meeting criteria for 1 of the following:

    • High-risk disease

      • Distant metastases (stage 4, group IV)
    • Intermediate-risk disease

      • Nonmetastatic undifferentiated sarcoma OR alveolar RMS OR ectomesenchymoma with alveolar features (regardless of age, site, size, stage, or degree of initial surgical resection)
      • Stage 2 or 3, group III embryonal RMS OR ectomesenchymoma with embryonal features
  • Newly diagnosed

    • Previously untreated
  • Biopsy or definitive surgery required within the past 42 days

PATIENT CHARACTERISTICS:

Age

  • 30 and under at diagnosis

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3*
  • Hemoglobin ≥ 9 g/dL*
  • Platelet count ≥ 100,000/mm^3* NOTE: *Unless there is bone marrow infiltration by tumor or presence of disseminated intravascular coagulation

Hepatic

  • Bilirubin < 2.5 times upper limit of normal (ULN)*
  • SGOT and SGPT < 2.5 times ULN* NOTE: *Unless there is hepatic involvement by tumor

Renal

  • Creatinine normal for age OR
  • Creatinine clearance or nuclear glomerular filtration rate at least 80 mL/min (in the absence of obstructive hydronephrosis)

Cardiovascular

  • Shortening fraction ≥ 28% by echocardiogram OR
  • LVEF ≥ 50% by MUGA

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior steroids allowed

Radiotherapy

  • No prior radiotherapy, except limited, emergent radiotherapy (e.g., treatment of threatened airway or spinal cord compromise)

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077285

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Leonard H. Wexler, MD     212-639-7990     wexlerl@mskcc.org    
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Leonard H. Wexler, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Leonard H. Wexler )
Study ID Numbers: CDR0000350083, MSKCC-03099
Study First Received: February 10, 2004
Last Updated: July 7, 2009
ClinicalTrials.gov Identifier: NCT00077285     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
previously untreated childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
adult rhabdomyosarcoma
stage IV adult soft tissue sarcoma
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
childhood malignant mesenchymoma
adult malignant mesenchymoma
stage III adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage I adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Irinotecan
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Razoxane
Neoplasms, Connective and Soft Tissue
Therapeutic Uses
Etoposide
Alkylating Agents
Rhabdomyosarcoma
Neoplasms by Histologic Type
Myosarcoma
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Cardiovascular Agents
Carboplatin
Immunosuppressive Agents
Doxorubicin
Camptothecin
Pharmacologic Actions
Ifosfamide
Neoplasms
Tubulin Modulators
Myeloablative Agonists

ClinicalTrials.gov processed this record on November 30, 2009