Status:
COMPLETED
IMC-A12 in Treating Young Patients With Relapsed or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor or Other Solid Tumor
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Unspecified Childhood Solid Tumor, Protocol Specific
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
This phase I clinical trial is studying the side effects and best dose of IMC-A12 in treating young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal tumor or oth...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) or recommended phase II dose of IMC-A12 (cixutumumab) in children with relapsed or refractory solid tumors using a limited dose-esc...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed solid tumor
- Relapsed or refractory disease
- No central nervous system (CNS) tumor or lymphoma
- Histological confirmation may have been made at original diagnosis or at relapse
- Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- Measurable or evaluable disease
- Patients with Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET) must have tissue blocks or slides available
- Study chair must be notified if tissue blocks or slides are not available
- Karnofsky performance status (PS) ≥ 50% (patients \> 10 years of age) and Lansky (PS) ≥ 50% (patients ≤ 10 years of age)
- Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
- 1 to \< 2 years (males and females 0.6 mg/dL)
- 2 to \< 6 years (males and females 0.8 mg/dL)
- 6 to \< 10 years (males and females 1.0 mg/dL)
- 10 to \< 13 years (males and females 1.2 mg/dL)
- 13 to \< 16 years (males 1.5 mg/dL and females 1.4 mg/dL)
- ≥ 16 years (males 1.7 mg/dL and females 1.4 mg/dL)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- SGPT (ALT) ≤ 110 μ/L (for the purpose of this study, the ULN for SGPT is 45 μ/L)
- Serum albumin ≥ 2 g/dL
- Patients with known bone marrow metastatic disease will be eligible for study but not evaluable for hematologic toxicity
- Patients must not be known to be refractory to red cell or platelet transfusion
- Patients with solid tumors without bone marrow involvement must meet the following criteria:
- Peripheral absolute neutrophil count ≥ 1,000/μL
- Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
- Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- No uncontrolled infection
- No known type I or type II diabetes mellitus
- Able to comply with the safety monitoring requirements of the study, in the opinion of the investigator
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12
- Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
- At least 7 days since prior and no concurrent hematopoietic growth factors
- Growth factors that support platelet or white cell number or function can only be administered for culture-proven bacteremia or invasive fungal infection
- At least 7 days since prior and no concurrent biologic antineoplastic agents
- At least 6 weeks since prior monoclonal antibodies
- At least 3 months since prior total body irradiation (TBI), craniospinal external radiotherapy (XRT), or ≥ 50% radiotherapy to the pelvis
- At least 2 weeks since prior local XRT (small port)
- At least 6 weeks since other prior substantial bone marrow radiotherapy
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
- More than 7 days since prior and no concurrent systemic corticosteroids
- Prior stem cell transplant or rescue allowed provided there has been no evidence of active graft-versus-host-disease within the past 2 months
- No prior monoclonal antibody therapy targeting the IGF-IR
- No concurrent chemotherapy, radiotherapy, or immunotherapy
- No concurrent anticancer agents
- No concurrent insulin or growth hormone therapy
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00609141
Start Date
January 1 2008
Last Update
June 19 2014
Active Locations (1)
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1
COG Phase I Consortium
Arcadia, California, United States, 91006-3776