MDACC Study Summary 2007-0403

Study Summary
No. 2007-0403:.......Pediatrics......Tribhawan S. Vats......Pediatrics

Study Summary Title



Study Summary Number:	2007-0403

Study Title:	Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM) in Pediatric Patients with Recurrent Diffuse Instrinsic Pontine Glioma

Physician

New Patient Referral



Name:	Tribhawan S. Vats	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6610 Contact us about clinical trials

General Information



Disease Group:	Pediatrics	Supported By:	The Childrens Hospital YM Biosciences Inc.

Phase of Study:	Phase II	Return Visit:	It is anticipated that the participants will come to MDACC for 18 visits, including pretreatment, treatment and post treatment.

Treatment Agents:	Nimotuzumab	Home Care:	None anticipated.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	No hospitalization is anticipated unless it becomes clinically necessary.


Description/ Intervention:	The goal of this clinical research study is to learn if nimotuzumab can help to control the disease in patients with diffuse intrinsic pontine glioma that has grown or has come back after surgery. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary Objectives

To determine the objective response rate.
To evaluate the safety profile of single agent nimotuzumab in this population.

Secondary Objectives

To determine overall survival
To determine clinical benefit rate
To determine response rate at week 18
To determine duration of response in responders
To determine time to progression
To evaluate symptom control
To evaluate changes in steroid requirements

Translational Objectives

Characterize the serum pharmacokinetics of nimotuzumab following the eighth dose
Evaluate whether there is acorrelation between time to death/response and levels of circulating progenitor cells (CEP) and circulating endothelial cells (CEC) cells

Study Status Information



Study Activation / Registration Date:	02/06/2008

IRB Review and Approval Date:	12/13/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	44

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient, parent, or legal representative must provide signed written informed consent

2) Patients with recurrent diffuse intrinsic pontine gliomas are eligible without histologic confirmation: At the time of initial diagnosis, the tumor must have had a pontine epicenter and exhibited diffuse rather than focal involvement of at least 2/3 of the pons, with or without extension to the adjacent medulla or midbrain. Such lesions typically exhibit T2 or FLAIR signal abnormality that extends throughout most and usually all of the pons (COG criteria).

3) At the time of initial diagnosis, patients must have had at least 2 of the following 3 neurological symptoms: cranial nerve deficit, long tract signs, ataxia, and an onset prior to initial diagnosis < 6 months.

4) Patients with evidence of clinical and/or radiological disease progression (Appendix 7) during initial therapy, or patients who have relapsed following prior therapy are eligible. No more than one course of prior therapy which must have included focal radiation at a dose>/= 54 Gy and may also have included chemotherapy is allowed.

5) Have a Lansky or Karnofsky Performance Status of > 40.

6) Be between the ages of >/= 3 years to </= 18 years at the time of initial diagnosis.

7) Have a tumor that is measurable radiologically in at least two dimensions.

8) For female patients of childbearing age, where child bearing age is defined as the period in a woman's life between puberty and menopause: Presence of a negative pregnancy test within 7 days prior to day 0.

9) The patient agrees to use effective contraception if procreative potential exists. Use of reliable means of contraception(e.g.hormonal contraceptive pathch, vaginal ring, intrauterine device, physical barrier, abstinence) for subjects of reproductive potential (males and females) is required during study treatment and for 3 months following last dose of study drug.

10) Adequate hematological, renal, and hepatic function as defined by: leukocyte count >/= 2000/uL, platelet count >/= 100,000/uL, ALT </= 2.5 x upper limit of normal, AST </= 2.5 x upper limit of normal, serum creatinine or estimated creatinine clearance </= 1.5 x upper reference range value, bilirubin </= 1.5 x upper limit of normal, hemoglobin >/= 10g/dL (following transfusion if necessary).

Exclusion Criteria:

1) A history of prior use of EGFR-targeting agents (monoclonal antibodies, tyrosine kinase inhibitors).

2) More than one line of prior treatment (i.e. more than one progression after initial therapy) for the disease.

3) Patients with disseminaed disease are not eligible. Patients with NF1 are excluded because the biological behavior of their tumors may be much more benign than those of non-NF1 patients, and this therapy may not be appropriate.

4) Does not meet the eligibility criteria of clinical and/or radiological disease progression as defined in Appendix 7.

5) Had radiation completed within 12 weeks of enrollment.

6) Previous chemotherapy completed < / = 2 weeks prior to enrollment.

7) If female, is pregnant or lactating.

8) Has other existing serious medical conditions that could adversely affect the ability of the patient to be treated in accordance with the protocol.

9) Has any condition, therapy, or medical condition which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives.

10) Is currently taking or planning to take other investigational drugs during the study.

11) Known contraindications against antibodies (e.g. severe allergies or an allergic reaction to prior treatment with recombinant/monoclonal antibodies).

Links

Registration Number: NCT00600054
Study Information on Clinical Trials Registry (clinicaltrials.gov)