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Investigator(s):
Elizabeth Fox, M.D. Principal Investigator Phone: 301-402-6641 foxb@mail.nih.gov	Meredith Chuk, M.D. Protocol Chair Phone: 301-594-6104
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• 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 tumor
• Germ cell tumor
• Brain tumor (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
• Recovered from all prior therapy
• Must have recovered to ≤ grade 1 from acute toxic effects of prior therapy
• ≥ 4 weeks since the last dose of radiation to ≥ 25% of marrow bones, ≥ 4 months since TBI and craniospinal radiation, and ≥ 2 weeks since palliative radiation
• ≥ 3 weeks since last dose of mylosuppressive anticancer drugs
• ≥ 7 days since non-mylosuppressive biological agents
• ≥ 30 days since the last dose of investigational agents
• ≥ 1 week since last dose of filgastrim or epoetin and 2 weeks since long acting colony stimulating factors, such as PEG-filgrastim
• ≥ 2 months since prior autologous stem cell transplantation
• No prior allogeneic stem cell transplantation
• Karnofsky performance status (PS) 60–100% (patients > 10 years of age) OR Lansky PS 60–100% (patients ≤ 10 years of age)
• ≥ 4 years and < 17 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 x 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 ≤ ULN
• Creatine kinase ≤ 2.5 x ULN; normal age-adjusted serum creatinine clearance ≥ 60 mL/min/1.73 m²
• No known history of xeroderma pigmentosum or other diseases with reduced DNA repair

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Treatment Plan:

This is a dose-escalation study.

• Patients receive trabectedin IV over 24 hours on Day 1
• Patients also receive dexamethasone pretreatment and filgrastim (G-CSF) subcutaneously (SC) beginning 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
• Blood is collected periodically for research studies
• Groups of 3–6 patients receive escalating doses of trabectedin until the maximum tolerated dose is determined

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/10/08
Updated: 7/31/08