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Study Summary
No. DM98-342:.......Leukemia......Jorge Cortes......Leukemia
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Study Summary Title
Study Summary
Number:
DM98-342
Study Title:PHASE I EVALUATION OF the Anti-CD-33 IMMUNOTOXIN HuM195/rGel
IN PATIENTS WITH ADVANCED MYELOID MALIGNANCIES
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Physician New Patient Referral
Name:Jorge CortesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3522
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IReturn
Visit:
2 weeks after treatment. Thereafter, patient may be taken off study or come
back for second treatment (Day 35) and 2 weeks after second treatment.
Treatment
Agents:
HUM195/RGELHome Care:NA
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
4 days in hospital (during first two week treatment period)
Description/
Intervention:
The goal of this clinical research study is to find the highest safe dose of
the anti-CD33 immunotoxin HuM-195/rGel that can be given to patients with
advanced myeloid malignancies. This treatment will be given to patients whose
leukemia has not responded to prior chemotherapy.
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Study Objectives / Outcomes
(1) To determine the safety and toxicity of HuM-195/rGel immunotoxin in patients with relapsed or refractory myeloid malignancies.
(2) To determine the pharmacology of HuM-195/rGel.
(3) To examine the biological effects of HuM-195/rGel including the ability to elicit antileukemic responses, human anti-human antibody (HAHA) and human anti-gelonin antibody (HAGA) responses.
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Study Status Information
Study Activation / Registration Date:05/19/1999
IRB Review and Approval Date:05/03/2005
Study Type:Phase I
Recruitment Status:Open
Projected Accrual:N/A
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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) Patients with relapsed or refractory AML, RAEB-t, RAEB, or CMML who failed at least one previous chemotherapy course. Patients with accelerated CML Ph+ or myeloid blastic crisis are eligible. Patients in accelerated phase of non-Philadelphia chromosome + myeloproliferative disorders are also eligible: 1) P. vera, 2) myelofibrosis, 3) essential thrombocytopenia with >5% blasts in the blood or bone marrow.)

2) Male or female 18 yrs of age or older who have provided written informed consent.

3) Tumor cells must be = or > 80% CD33 positive by flow cytometry.

4) For women of childbearing potential (i.e. exclude post-menopausal women, women who have been surgically sterilized), adequate birth control methods must be used. Acceptable birth control methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with a condom.

5) WBC count <10,000/ml for AML, MDS, and myeloproliferative disorders and up to 30,000 for accelerated CML.

6) No cytotoxic chemotherapy for the two weeks prior to entering the study.

7) No evidence of residual toxic effects grade 2 or higher from prior chemotherapy.

8) Patients with proven bacterial infection are not eligible until resolution of the infection (patient afebrile, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and they do not have fever exceeding 38°C.

9) Creatinine - Patients should have values = or < 1.5 times the upper limit of laboratory normal values.

10) Liver function - Patients should have serum bilirubin values = or < 2.0 times the upper limit of laboratory normal values. Patients should have SGOT and/or SGPT levels = or < 2.5 times the upper limit of laboratory normal values.

11) Cardiac function – Patients with cardiovascular disease should be < NYHA classification III

12) Pulmonary function – O2 saturation should be = or > 92% without exogenous O2 administered.

13) Neurologic function – Patients should have normal central nervous system function as well as normal motor function consistent with = or < Grade 1 toxicity. Patients should have peripheral sensory function damage (neuropathy) not exceeding Grade 1 toxicity

Exclusion Criteria:1) Women who are pregnant or lactating.

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Links
Registration Number: NCT00038051
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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