CompletedPhase 2

Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

United States, Canada50 participantsStarted 2008-01

Plain-language summary

This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.

Who can participate

Age range

12 Months – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must be greater than or equal to 12 months of age at the time of study entry and no more than 21 years of age when initially diagnosed with the malignancy to be treated on this protocol * Histologically confirmed recurrent or refractory sarcoma tumors, 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 * Performance status - Lansky 50-100% (10 years of age and under) * Performance status - Karnofsky 50-100% (over 10 years of age) * 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) * 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., zafirlukas…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response (Complete Response [CR] and Partial Response [PR])

Timeframe: Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.

Number of Patients With Dose-Limiting Toxicity (DLT)

Timeframe: 1 Cycle

Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin

Timeframe: From baseline up to168 hours after trabectedin infusion in course 1

Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin

Timeframe: From baseline up to168 hours after trabectedin infusion in course 1

Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin

Timeframe: From baseline up to168 hours after trabectedin infusion in course 1

Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin

Timeframe: From baseline up to168 hours after trabectedin infusion in course 1

Trial details

NCT IDNCT00070109

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2010-10

Results submitted2013-12-09

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