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Status:

COMPLETED

Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adult Rhabdomyosarcoma

Adult Synovial Sarcoma

Eligibility:

All Genders

7-30 years

Phase:

PHASE2

Brief Summary

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 tum...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the response rate to IMC-A12 (cixutumumab) administered in various strata of recurrent/refractory malignant solid tumors in childhood and young adulthood. II. To ...

Eligibility Criteria

Inclusion

  • 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 post-radiotherapy
  • 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 neuroblastoma)
  • 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 allowed)
  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2013

    Estimated Enrollment :

    116 Patients enrolled

    Trial Details

    Trial ID

    NCT00831844

    Start Date

    January 1 2009

    End Date

    October 1 2013

    Last Update

    March 30 2015

    Active Locations (105)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 27 (105 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    3

    Southern California Permanente Medical Group

    Downey, California, United States, 90242

    4

    Miller Children's Hospital

    Long Beach, California, United States, 90806