MDACC Study Summary 2009-0042

Study Summary
No. 2009-0042:.......Leukemia......Jorge Cortes......Leukemia

Study Summary Title



Study Summary Number:	2009-0042

Study Title:	An Open-Label, Dose-Escalation, Phase I Study of IMC-EB10 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

Physician

New Patient Referral



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

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

Phone:	713-794-5783 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Imclone Systems Incorporated

Phase of Study:	Phase I	Return Visit:	once weekly

Treatment Agents:	IMC-EB10	Home Care:	All treatment is to be administered at MDACC.

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

Estimated Length of Stay in Houston:	None anticipated; however, will admit to hematology beds if the patient is admitted for adverse reactions or suspected side effects from this agent.


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Primary Objectives

The primary objectives are to define the maximum tolerated dose (MTD) and the pharmacokinetic (PK) profile of the anti-FLT3 monoclonal antibody IMC-EB10, administered weekly in patients with AML who have failed to achieve complete remission to a standard induction regimen, relapsed after response to previous antileukemia therapy, or are not eligible for potentially curative or approved salvage options.

Secondary Objectives

characterize the safety profile of IMC-EB10
define the recommended Phase 2 dose (RP2D)
screen for the development of antibodies against IMC-EB10
assess the antileukemic response to IMC-EB10 as monotherapy
describe the hematologic response to IMC-EB10 in relation to the FLT3 status (wild type, ITD mutation, and other mutations)

Study Status Information



Study Activation / Registration Date:	05/21/2009

IRB Review and Approval Date:	04/14/2009

Study Type:	Phase I

Recruitment Status:	Open

Projected Accrual:	25-30

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) The patient has cytopathologically documented AML in the bone marrow or blood that has relapsed with or without a prior complete remission.

2) The patient is not regarded to be a candidate for a potentially curative, higher priority treatment for AML.

3) The patient has resolution of all clinically significant toxic effects of any prior antitumor therapy to Grade </= 1 by NCI-CTCAE v 3.0. Exceptions include alopecia, hematologic parameters, and any other study-specific clinical or laboratory parameter specified in the entry criteria.

4) The patient has not had major surgery, an open biopsy, a significant injury, and/or prior antitumor therapy (except antileukemia therapy) within 21 days prior to the first infusion of IMC-EB10.

5) The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at study entry.

6) The patient is age 18 years or older.

7) The patient has a life expectancy of > 3 months.

8) The patient has adequate hepatic function, as defined by the following criteria: total bilirubin level </= 2.0 times the upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) levels </= 2.5 times the ULN; alkaline phosphatase level </= 2.5 times the ULN.

9) The patient has adequate renal function, as defined by the following criteria: a serum creatinine level </= 1.5 mg/dL; urinalysis with no clinically significant findings.

10) The patient is using an effective contraception (per the institutional standard), if procreative potential exists.

11) The patient is able to give written informed consent.

12) The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans.

Exclusion Criteria:

1) The patient has had prior allogenic or autologous stem cell transplant within < 3 months of the first infusion of IMC-EB10.

2) The patient has had an organ transplant (nonhematologic) within 3 years of study entry.

3) The patient has active central nervous system leukemia.

4) The patient has extramedullary disease without peripheral/and or bone marrow involvement.

5) The patient is disease-free from a previous or concurrent malignancy for a period </= 1 year. A patient who has basal cell carcinoma or carcinoma in situ of the cervix will not be excluded from the study. The presence of other localized cancers need to be discussed with the ImClone Medical Monitor prior to enrollment in the study.

6) The patient is currently receiving antileukemia therapy. Concurrent treatment with hydroxyurea is permitted.

7) The patient has uncontrolled intercurrent illness including, but not limited to the following: an ongoing or active infection requiring parenteral antibiotics; symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease); unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months prior to the first dose of study medication; uncontrolled hypertension; uncontrolled or clinically significant cardiac arrhythmia; uncontrolled diabetes;

8) **continued from above: uncontrolled psychiatric illness or social situations that would compromise patient safety or limit compliance with study requirements; uncontrolled central nervous system metastases; active or chronic viral hepatitis; known advanced or uncontrolled human immunodeficiency virus infection.

9) The patient is receiving chronic steroid or other immunosuppressive medications. Occasional use of steroid-containing medications, eg, for asthma exacerbation or for skin lesions, is permitted.

10) The patient is receiving full-dose heparin (including low molecular weight heparin) or warfarin. (The patient is permitted to use low-dose warfarin to maintain patency of preexisting, permanent, indwelling I.V. catheters.)

11) The patient is pregnant (confirmed by urine or serum pregnancy test) or breast feeding.

12) The patient has received treatment with monoclonal antibodies within 6 weeks prior to first infusion of IMC-EB10.

13) The patient has a history of clinically significant allergic reactions to monoclonal antibodies or other therapeutic proteins.

Links

Registration Number: NCT00887926
Study Information on Clinical Trials Registry (clinicaltrials.gov)