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Trabectedin in Treating Young Patients With Solid Tumors That Have Relapsed or Not Responded to Treatment
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00437047
  Purpose

RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of trabectedin in treating young patients with solid tumors that have relapsed or not responded to treatment.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Kidney Cancer
Liver Cancer
Neuroblastoma
Ovarian Cancer
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: filgrastim
Drug: pegfilgrastim
Drug: trabectedin
Phase I

MedlinePlus related topics: Cancer Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma Wilms' Tumor
Drug Information available for: Filgrastim Pegfilgrastim Ecteinascidin 743
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial and Pharmacokinetic Study of Trabectedin (Yondelis®, ET-743) in Children and Adolescents With Relapsed or Refractory Solid Tumors

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

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: June 2008
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of trabectedin in pediatric patients with relapsed or refractory solid tumors.
  • Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive trabectedin IV over 24 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 and continuing until blood counts recover OR pegfilgrastim SC once on day 3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-12 patients receive escalating doses of trabectedin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 4 of 12 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor, including, but not limited to, any of the following:

    • Rhabdomyosarcoma or other soft tissue sarcomas
    • Ewing's sarcoma family of tumors
    • Osteosarcoma
    • Neuroblastoma
    • Wilms' tumor
    • Hepatic tumors
    • Germ cell tumors
    • Brain tumors

      • Must be on a stable or tapering dose of corticosteroids for 7 days before the baseline scan
  • Measurable or evaluable disease
  • Relapsed disease OR failed to respond to front-line curative therapy and no other potentially curative treatment options are available

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 60-100% (patients > 10 years of age) OR Lansky PS 60-100% (patients ≤ 10 years of age)
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³ (transfusion independent)
  • Hemoglobin ≥ 8 g/dL (transfusion allowed)
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin normal (unless elevation is due to Gilbert's syndrome and approved by the principal investigator)
  • Alkaline phosphatase normal OR 5' nucleotidase normal
  • Creatine kinase ≤ 2.5 times ULN
  • Creatinine clearance ≥ 60 mL/min OR age-adjusted creatinine meeting the following criteria:

    • No greater than 0.8 mg/dL (≤ 5 years of age)
    • No greater than 1.0 mg/dL (6-10 years of age)
    • No greater than 1.2 mg/dL (11-15 years of age)
    • No greater than 1.5 mg/dL (≥ 15 years of age)
  • No severe uncontrolled infections or other unrelated systemic illnesses that would preclude compliance with study requirements
  • No known history of xeroderma pigmentosum or other diseases with reduced DNA repair
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • At least 3 weeks since prior myelosuppressive chemotherapy
  • At least 1 week since prior growth factors (e.g., filgrastim [G-CSF] or epoetin alfa)
  • At least 2 weeks since prior long-acting colony-stimulating factors (e.g., pegfilgrastim)
  • At least 30 days since prior anticancer investigational agents
  • At least 1 week since prior nonmyelosuppressive biologic therapy (e.g., retinoids)
  • At least 4 weeks since prior radiotherapy to > 25% of marrow-containing bones (e.g., pelvis, spine, skull)
  • At least 4 months since prior total-body irradiation or craniospinal radiotherapy
  • At least 2 weeks since prior palliative radiotherapy
  • At least 2 months since prior autologous stem cell transplantation
  • No prior trabectedin
  • No prior allogeneic stem cell transplantation
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or immunotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437047

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: Elizabeth Fox, MD NCI - Pediatric Oncology Branch
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000529908, NCI-07-C-0054
Study First Received: February 15, 2007
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00437047  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific
recurrent childhood brain stem glioma
recurrent childhood cerebellar astrocytoma
childhood atypical teratoid/rhabdoid tumor
previously treated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic osteosarcoma
recurrent osteosarcoma
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
stage IV Wilms tumor
stage V Wilms tumor
recurrent childhood liver cancer
stage IV childhood liver cancer
childhood central nervous system germ cell tumor
childhood extragonadal germ cell tumor
childhood malignant ovarian germ cell tumor
childhood malignant testicular germ cell tumor
recurrent childhood malignant germ cell tumor
childhood choroid plexus tumor
childhood craniopharyngioma
childhood infratentorial ependymoma
childhood supratentorial ependymoma
childhood teratoma
childhood oligodendroglioma
childhood grade I meningioma
childhood grade II meningioma

Study placed in the following topic categories:
Ecteinascidin 743
Liver Diseases
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Urogenital Neoplasms
Central Nervous System Neoplasms
Urologic Neoplasms
Osteogenic sarcoma
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Neuroepithelioma
Glioma
Kidney Diseases
Nervous System Neoplasms
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Digestive System Neoplasms
Astrocytoma
Genital Neoplasms, Female
Endocrine System Diseases
Renal cancer
Testicular Neoplasms
Rhabdoid tumor
Carcinoma
Brain Neoplasms
Neuroectodermal Tumors
Sarcoma
Gastrointestinal Neoplasms
Testicular cancer
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009