CompletedPhase 2

Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma

United States, Australia, Canada175 participantsStarted 2010-01

Plain-language summary

This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with combination chemotherapy may kill more tumor cells.

Who can participate

Age range

49 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 eligible for, and enrolled on D9902 prior to enrollment on ARST08P1 * Patients with newly diagnosed, biopsy-proven metastatic rhabdomyosarcoma or ectomesenchymoma (stage IV, clinical group IV) are eligible for this study; patients with stage IV, clinical group IV RMS with parameningeal and paraspinal primary tumors, including those with intracranial extension (ICE) are eligible for ARST08P1; ICE is defined by contrast magnetic resonance imaging (MRI) showing that the primary tumor touches, displaces, invades, distorts, or otherwise causes signal abnormality of the dura in brain or spinal cord in contiguity to the primary site; ICE is also presumed to exist if the cerebrospinal fluid (CSF) cytopathology is positive for tumor at diagnosis * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * No prior chemotherapy or radiotherapy except for use of corticosteroids or emergent radiation therapy; patients requiring emergency radiation are eligible * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73m\^2 OR maximum serum creatinine based on age/gender as follows: * 0.4 mg/dL (for patients 1 to 5 months of age) * 0.5 mg/dL (for patients 6 to 11 months of age) * 0.6 mg/dL (for patients 1 year of age) * 0.8 mg/dL (for patients 2 to 5 years of…

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

Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment

Timeframe: From start to week 26 of therapy

Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment

Timeframe: From start to week 26 of therapy

Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0

Timeframe: Up to 54 weeks

Event-Free Survival

Timeframe: 3 years

Trial details

NCT IDNCT01055314

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2016-08-18

View on ClinicalTrials.gov More Adult Rhabdomyosarcoma trials

Plain-language summary

Who can participate

Age range

49 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.

What they're measuring

Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment

Timeframe: From start to week 26 of therapy

Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment

Timeframe: From start to week 26 of therapy

Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0

Timeframe: Up to 54 weeks

Event-Free Survival

Timeframe: 3 years