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

Not Recruiting

Trial ID: NCT01055314


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.

Official Title

A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody NSC # 742460]) in Combination With Intensive Multi-agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma

Stanford Investigator(s)


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

   - 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 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)

   - Patients with urinary tract obstruction by tumor must meet the renal function criteria
   listed above AND must have unimpeded urinary flow established via decompression of the
   obstructed portion of the urinary tract

   - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, unless there is evidence
   of biliary obstruction by the tumor

   - Shortening fraction >= 27% by echocardiogram (ECHO) OR ejection fraction >= 50% by
   radionuclide angiogram

   - Absolute neutrophil count (ANC) >= 750/uL; abnormal blood counts are permissible if
   there is bone marrow biopsy or aspirate proven bone marrow involvement by

   - Platelet count >= 75,000/uL; abnormal blood counts are permissible if there is bone
   marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma

   - Sexually active patients of childbearing potential must agree to use effective
   contraception during therapy (Pilots 1 and 2) and for at least 3 months after the last
   dose of IMC-A12 (Pilots 1)

Exclusion Criteria:

   - Female patients who are pregnant are not eligible

   - Female patients who are breastfeeding are not eligible; female patients who are
   lactating must agree to stop breastfeeding to participate in this study

   - Patients receiving growth hormone therapy are not eligible

   - Patients with known type I or type II diabetes mellitus are not eligible for
   enrollment on Pilot 1

   - Patients with evidence of uncontrolled infection are not eligible

   - All patients and/or their parents or legal guardians must sign a written informed

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met


biological: cixutumumab

biological: dactinomycin

drug: cyclophosphamide

drug: doxorubicin hydrochloride

drug: etoposide

drug: ifosfamide

drug: irinotecan hydrochloride

drug: temozolomide

other: laboratory biomarker analysis

drug: Vincristine Sulfate Liposome

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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