Clinical trial · Interventional
IMC-A12 in Treating Young Patients With Relapsed or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor or Other Solid Tumor
A Phase I Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, NSC #742460) in Children With Relapsed/Refractory Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 other solid tumors. Monoclonal antibodies, such as IMC-A12, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | CURATED_BROADER | 0.78 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cixutumumab | Biological | Cixutumumab | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (monoclonal antibody therapy)
- description
- Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for up to 2 years in the absence of unacceptable toxicity or disease progression.
- interventionNames
- Biological: cixutumumab
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
- timeFrame
- Weekly during each course
- description
- Toxicity tables will be constructed to summarize the observed incidence by severity and type of toxicity.
- measure
- MTD or recommended phase II dose
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available