Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex

ALL

Age

1 Year - 21 Years

Healthy Volunteers

Not accepted

Interventions

• ziv-aflibercept — BIOLOGICAL
  Given IV

Study Details

This phase I trial is studying the side effects and best dose of aflibercept in treating young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor.

Key Dates

Start date

Apr 30, 2008

Status verified

Oct 2011

Primary completion

Feb 28, 2010

Study Design

Enrollment

27 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (ziv-aflibercept)
  PART 1: Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for 2 years in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive aflibercept until the maximum tolerated dose (MTD) is determined. PART 2: Patients receive aflibercept as in part 1 at 150% of the MTD determined in part 1. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose, defined as the maximum dose at which fewer than one-third of patients experience DLT during the initial 2 courses of therapy, graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 28 days ]

Locations (6)

Find similar trials in Chicago, IL

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  Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina