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A Phase I Study Of Irinotecan and Bevacizumab With Temozolomide in Children With Recurrent/Refractory Central Nervous System Tumors


Phase 1
18 Months
23 Years
Open (Enrolling)
Both
Central Nervous System Tumors

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Trial Information

A Phase I Study Of Irinotecan and Bevacizumab With Temozolomide in Children With Recurrent/Refractory Central Nervous System Tumors


Inclusion Criteria:



- Medulloblastomas, high-grade glioma, low-grade glioma, and ependymoma are eligible.
Other central nervous system tumors may be considered for treatment at discretion of
investigator. Pathology is required unless diffuse intrinsic pontine glioma or optic
pathway tumor.

- The patient should have failed first line therapy and be considered refractory,
relapsed, or recurrent. Exceptions are high grade gliomas including brain stem
gliomas.

- Age 18 months though age 23 years are eligible for this protocol.

- The patient may have received any of the agents, but not in this combination.
Patients will not be eligible if they have received the combination of bevacizumab
and IV irinotecan as prior therapy. They will not be eligible if they had
progressive disease on any of these agents. Investigator discretion may also be
used.

- Bone marrow should be recovered from prior therapy with ANC >1500 and platelets
>100,000.

- Serum creatinine should be less than institutional upper limit of norm.

- ALT/AST <3 times normal and bilirubin <1.5 times normal.

- Neurologic symptoms should be stable for 1 week with stable or decreasing doses of
steroids.

- Patients should not be pregnant or breast feeding.

Exclusion Criteria:

- Patients with bleeding disorders or on anticoagulants.

- Uncontrolled hypertension.

- Other risks of bleeding determined on individual basis.

- Patients receiving enzyme inducing anticonvulsants.

- Patients with significant cardiac or pulmonary dysfunction that would compromise the
patient's ability to tolerate protocol therapy or would likely interfere with the
study procedures or results.

- For patients receiving bevacizumab, those who have had surgical procedures should not
receive bevacizumab within 28 days of a major procedure, 14 days of an intermediate
procedure and 7 days of a minor procedure. Lumbar punctures or placement of PICC
lines are not considered minor procedures and may occur at any time prior to or
during therapy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To conduct a phase I study to evaluate the safety of this combination of chemotherapy agents.

Outcome Time Frame:

Every 2 months (every 2 cycles)

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

ACH-CNS-001

NCT ID:

NCT00876993

Start Date:

September 2008

Completion Date:

September 2013

Related Keywords:

  • Central Nervous System Tumors
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

All Children's HospitalSt. Petersburg, Florida  33701