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Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: October 3, 2003   Last Updated: November 18, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070109
  Purpose

RATIONALE: Drugs used in chemotherapy such as ecteinascidin 743 use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well ecteinascidin 743 works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors.


Condition Intervention Phase
Sarcoma
Drug: trabectedin
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcoma

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 ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2008
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewing's sarcoma family of tumors treated with ecteinascidin 743.
  • Determine the toxicity of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma family of tumors vs rhabdomyosarcoma vs nonrhabdomyosarcomatous soft tissue sarcoma).

Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 30-60 patients (10-20 per stratum) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or refractory sarcomas, including the following:

    • Rhabdomyosarcoma
    • Nonrhabdomyosarcomatous soft tissue sarcoma
    • Ewing's sarcoma
  • Measurable disease by imaging studies

    • Lesions assessable only by radionuclide scans are not considered measurable
    • If the only measurable lesion has been previously irradiated, then that lesion must have shown evidence of an interim increase in size
  • No significant amount of metastatic liver disease, defined as the following:

    • Lesions occupying more than 25% of the liver by imaging and abnormal liver function tests or abnormal synthetic liver function

PATIENT CHARACTERISTICS:

Age

  • 21 and under (at time of diagnosis)

Performance status

  • Lansky 50-100% (10 years of age and under)
  • Karnofsky 50-100% (over 10 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3 (transfusion independent)
  • Hemoglobin at least 8.0 g/dL (transfusion allowed)

Hepatic

  • See Disease Characteristics
  • Bilirubin no greater than upper limit of normal (ULN)
  • Total alkaline phosphatase no greater than ULN OR
  • Hepatic fraction alkaline phosphatase and 5 nucleotidase no greater than ULN
  • SGOT and SGPT normal for age
  • Albumin at least 2.5 g/dL

Renal

  • Maximum creatinine based on age as follows:

    • 0.8 mg/dL (5 years of age and under)
    • 1.0 mg/dL (6 to 10 years of age)
    • 1.2 mg/dL (11 to 15 years of age)
    • 1.5 mg/dL (over 15 years of age) OR
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min

Cardiovascular

  • No uncompensated congestive heart failure within the past 6 months

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 2 months after study participation
  • No active uncontrolled infection
  • Weight ≥ 15 kilograms

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 1 week since prior growth factors that support platelet or white blood cell number or function
  • At least 7 days since prior biologic agents and recovered
  • No prior allogeneic stem cell transplantation
  • No other concurrent immunomodulating agents

Chemotherapy

  • More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No more than 2 prior multi-agent chemotherapy regimens
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Concurrent steroids allowed

Radiotherapy

  • See Disease Characteristics
  • At least 6 weeks since prior since prior extended radiotherapy and recovered
  • No prior total body radiotherapy
  • Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated* NOTE: *Any irradiated lesion cannot be used to assess tumor response

Surgery

  • Not specified

Other

  • At least 7 days since prior enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin)
  • No concurrent enzyme-inducing anticonvulsants
  • No other concurrent investigational agents
  • No concurrent CYP3A4 inhibitors, including the following:

    • Grapefruit juice
    • Erythromycin
    • Azithromycin
    • Clarithromycin
    • Rifampin and its analogs
    • Fluconazole
    • Ketoconazole
    • Itraconazole
    • Cimetidine
    • Cannabinoids (marijuana or dronabinol)
    • Leukotriene inhibitors used in asthma (e.g., zafirlukast, montelukast, or zileuton)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070109

  Show 81 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Sylvain Baruchel, MD The Hospital for Sick Children
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers: CDR0000329999, COG-ADVL0221
Study First Received: October 3, 2003
Last Updated: November 18, 2009
ClinicalTrials.gov Identifier: NCT00070109     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent childhood rhabdomyosarcoma
previously treated childhood rhabdomyosarcoma
recurrent childhood soft tissue sarcoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Ecteinascidin 743
Neoplasms, Muscle Tissue
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myosarcoma
Osteosarcoma
Pharmacologic Actions
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Neoplasms
Neoplasms, Bone Tissue
Therapeutic Uses
Sarcoma
Neoplasms, Connective Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Rhabdomyosarcoma

ClinicalTrials.gov processed this record on November 22, 2009