Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

Not Recruiting

Trial ID: NCT00831844


This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. 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.

Official Title

A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, NSC #742460) in Children With Relapsed/Refractory Solid Tumors

Stanford Investigator(s)


Inclusion Criteria:

   - Histologically confirmed malignant solid tumor, including the following:

      - Osteosarcoma

      - Ewing sarcoma/peripheral primitive neuroectodermal tumor

      - Rhabdomyosarcoma

      - Neuroblastoma

      - Wilms tumor

      - Synovial sarcoma

      - Hepatoblastoma

      - Adrenocortical carcinoma

      - Retinoblastoma

   - No known curative therapy or therapy proven to prolong survival with an acceptable
   quality of life exists

   - Radiographically measurable disease*, defined as ≥ 1 unidimensionally measurable
   lesion ≥ 20 mm by MRI or CT scan or ≥ 10 mm by spiral CT scan

      - The following are not considered measurable disease:

         - Ascites, pleural effusions, or other malignant fluid collections

         - Bone marrow infiltration by tumor

         - Lesions detected only by non-MIBG nuclear medicine studies (e.g., bone scan)

         - Previously irradiated lesions that have not demonstrated clear progression

   - No known Central Nervous System (CNS) metastases unless they were treated by surgery
   or radiotherapy AND are stable with no recurrent lesions for ≥ 3 months

   - Lansky or Karnofsky performance status (PS) 50-100% OR Eastern Cooperative Oncology
   Group (ECOG) PS 0-2

   - Absolute neutrophil count (ANC) ≥ 1,000/mm³ (> 250/mm³ for patients with

   - Platelet count ≥ 75,000/mm³ (> 25,000/mm³ for patients with neuroblastoma)
   (transfusion independent)

   - Hemoglobin ≥ 8.0 g/dL (≥ 7.5 g/dL for patients with neuroblastoma) (RBC transfusion

   - Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum
   creatinine normal 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 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)

   - Total bilirubin ≤ 1.5 times upper limit of normal for age

   - Alanine transaminase (ALT) ≤ 110 U/L

   - Serum albumin ≥ 2 g/dL

   - Blood glucose normal

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception during and for 3 months after
   completion of study treatment

   - Able to comply with safety monitoring requirements of study

   - No history of allergic reactions attributed to compounds of similar chemical or
   biologic composition to study drug

   - No uncontrolled infection

   - No known type I or II diabetes mellitus

   - Recovered from prior chemotherapy, immunotherapy, or radiotherapy

   - More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)

   - At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim)

   - At least 6 weeks since prior monoclonal antibody therapy

   - At least 7 days since other prior antineoplastic biologic agents

   - No prior monoclonal antibody targeting the IGF-IR

   - No prior small molecule kinase inhibitors of IGF-IR

   - At least 2 weeks since prior local palliative (small port) radiotherapy

   - At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or
   radiotherapy to ≥ 50% of the pelvis

   - At least 6 weeks since other prior substantial bone marrow radiotherapy

   - At least 2 months since prior stem cell transplantation

      - No evidence of graft-versus-host disease

   - Concurrent corticosteroids allowed provided dose is stable or decreasing over the past
   7 days

      - Intermittent use of corticosteroids to manage infusional reactions allowed

   - No other concurrent anticancer therapy, including chemotherapy, radiotherapy,
   immunotherapy, or biologic therapy

   - No other concurrent investigational agents

   - No concurrent insulin or growth hormone therapy


other: laboratory biomarker analysis

biological: cixutumumab

Not Recruiting

Contact Information

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

New Trial Alerts

Receive email alerts when trials open to patients.