Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

Part of paid clinical trials in New York, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00729157
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Thyroid Gland Carcinoma
  • Stage III Thyroid Gland Follicular Carcinoma
  • Stage III Thyroid Gland Papillary Carcinoma
  • Stage IV Thyroid Gland Follicular Carcinoma
  • Stage IV Thyroid Gland Papillary Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fludeoxyglucose F-18 — RADIATION
    Correlative studies
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Positron Emission Tomography — PROCEDURE
    Correlative studies
  • Ziv-Aflibercept — BIOLOGICAL
    Given IV

Study Details

This phase II trial is studying how well aflibercept works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine therapy. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor and by carrying tumor-killing substances directly to thyroid cancer cells.

Key Dates

Start date
Aug 31, 2008
Status verified
Jan 2017
Primary completion
Oct 31, 2012
Completion
Nov 30, 2012

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ziv-aflibercept and fludeoxyglucose F 18)
    Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.

Primary Outcome Measure

Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

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Memorial Sloan-Kettering Cancer Center· New York, NY