Temozolomide or Cixutumumab and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
Status: Recruiting
Phase: N/A
Diagnosis: Pediatric Sarcoma
NCT ID: NCT01055314
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-124
RATIONALE: 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 or cixutumumab together with combination chemotherapy may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and how well giving temozolomide or cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma.
Conducting Institutions:
Children's Hospital Boston, Dana-Farber Cancer Institute
Overall PI:
Carlos Rodriguez-Galindo, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed, biopsy-confirmed metastatic rhabdomyosarcoma (RMS) or
ectomesenchymoma, including the following:
- Embryonal RMS (for patients 10 to 49 years of age)
- Alveolar RMS or ectomesenchymoma (for patients under 50 years of age)
- RMS with parameningeal and paraspinal primary tumors, including those with
intracranial extension by contrast 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, are allowed
- Has undergone initial surgery (including biopsy) that provided the definitive
diagnosis within the past 42 days
- Enrollment on COG-D9902 required
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2
- ANC ≥ 750/μL*
- Platelet count ≥ 75,000/μL*
- Creatinine clearance or radioisotope GFR ≥ 70 mL/min 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 age)
- 1.0 mg/dL (for patients 6 to 9 years of age)
- 1.2 mg/dL (for patients 10 to 12 years of age)
- 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
- 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
- Urinary tract obstruction by tumor allowed provided the above renal function criteria
are met AND there is unimpeded urinary flow established via decompression of the
obstructed portion of the urinary tract
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age (unless there is
evidence of biliary obstruction by the tumor)
- Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by radionuclide
angiogram
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after the
last dose of cixutumumab
- No uncontrolled infection
- No known type I or type II diabetes mellitus (for patients enrolled in groups 1 or 3)
NOTE: *Abnormal blood counts allowed provided bone marrow biopsy or aspirate confirm
bone marrow involvement by RMS
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy except corticosteroids or emergent radiotherapy
- No concurrent growth hormone therapy
- No concurrent sargramostim