Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
This study is currently recruiting participants.
Verified April 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01055314
First received: January 22, 2010
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
This 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.
| Condition | Intervention |
|---|---|
|
Adult Rhabdomyosarcoma Alveolar Childhood Rhabdomyosarcoma Embryonal Childhood Rhabdomyosarcoma Metastatic Childhood Soft Tissue Sarcoma Previously Untreated Childhood Rhabdomyosarcoma Stage IV Adult Soft Tissue Sarcoma |
Biological: cixutumumab Drug: doxorubicin hydrochloride Drug: irinotecan hydrochloride Drug: liposomal vincristine sulfate Drug: ifosfamide Drug: etoposide Drug: cyclophosphamide Biological: dactinomycin Drug: temozolomide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC #742460]) in Combination With Intensive Multi-Agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Dactinomycin
Vincristine sulfate
Ifosfamide
Sulfate ion
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Temozolomide
Irinotecan
Irinotecan hydrochloride
Etoposide phosphate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response rate assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]An O'Brien-Fleming monitoring boundary (truncated at 3 standard deviations) and a spending function approach will be employed for interim monitoring of efficacy. A futility analysis will also be performed, testing a 'null hypothesis' that the relative risk of failure with this therapy is 0.60 (compared to the ID/IE therapy experience), with consideration of suspension of accrual should this hypothesis be rejected at any of the scheduled interim looks at a significance level of 0.005.
- Event-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 (chemotherapy, radiation therapy, cixutumumab)
Patients receive vincristine sulfate IV on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50, and 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47, and 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, and 30; doxorubicin hydrochloride IV on days 1 and 2 of weeks 7, 11, 15, 28, and 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41, and 44; dactinomycin IV on day 1 of weeks 35, 38, 41, and 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiotherapy on days 1-5 of weeks 20-24.
|
Biological: cixutumumab
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: irinotecan hydrochloride
Given IV
Other Names:
Drug: liposomal vincristine sulfate
Given IV
Other Names:
Drug: ifosfamide
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Biological: dactinomycin
Given IV
Other Names:
|
|
Experimental: Group 2 (chemotherapy, radiation therapy, temozolomide)
Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiotherapy as in group 1. Patients also receive oral temozolomide on days 1-5 of weeks 1, 4, 20, 23, 47, and 50.
|
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: irinotecan hydrochloride
Given IV
Other Names:
Drug: liposomal vincristine sulfate
Given IV
Other Names:
Drug: ifosfamide
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Biological: dactinomycin
Given IV
Other Names:
Drug: temozolomide
Given orally
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Month to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Newly diagnosed, biopsy-confirmed metastatic rhabdomyosarcoma (RMS) or ectomesenchymoma
- Stage IV, Clinical Group IV
- RMS with parameningeal and paraspinal primary tumors, including those with intracranial extension 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, are allowed; ICE is also presumed to exist if the cerebrospinal fluid (CSF) cytopathology is positive for tumor at diagnosis
- Has undergone initial surgery (including biopsy) that provided the definitive diagnosis within the past 42 days
- Enrollment on COG-D9902 required
- 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
Absolute neutrophil count (ANC) >= 750/μL
- Abnormal blood counts are permissible if there is bone marrow biopsy or aspirate proven bone marrow involvement by RMS
Platelet count >= 75,000/μL
- Abnormal blood counts are permissible if there is bone marrow biopsy or aspirate proven bone marrow involvement by RMS
Creatinine clearance or radioisotope glomerular filtration rate (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)
- 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 times 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
- Not pregnant or nursing
- Negative pregnancy test
- Sexually active patients of childbearing potential must agree to use effective contraception during therapy (groups1 and 2) and for at least 3 months after the last dose of cixutumumab (group 1)
- No uncontrolled infection
- No known type I or type II diabetes mellitus (for patients enrolled in group 1)
No prior chemotherapy or radiotherapy except corticosteroids or emergent radiotherapy
- Patients requiring emergency radiation are eligible
- No concurrent growth hormone therapy
- All patients and/or their parents or legal guardians must sign a written informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055314
Show 134 Study Locations
Show 134 Study LocationsSponsors and Collaborators
Investigators
| Principal Investigator: | Suman Malempati | Children's Oncology Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01055314 History of Changes |
| Other Study ID Numbers: | NCI-2011-02005, ARST08P1, CDR0000663937, COG-ARST08P1, U10CA098543 |
| Study First Received: | January 22, 2010 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhabdomyosarcoma Rhabdomyosarcoma, Embryonal Sarcoma Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Dactinomycin Doxorubicin Etoposide phosphate Isophosphamide mustard Temozolomide Irinotecan Cyclophosphamide |
Etoposide Ifosfamide Vincristine Dacarbazine Camptothecin Antibodies Antibodies, Monoclonal Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013