Evaluation of the Anti-CD-33 Immunotoxin Hum-195/rGel in Patients With Advanced Myeloid Malignancies

NCT00038051 | Completed Phase 1 DMC

• 1 other identifier: DM98-342
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; Myeloproliferative Disorders; Anemia, Refractory, With Excess of Blasts

Keywords

Acute Myeloid Leukemia; AML; Chronic Myelomonocytic Leukemia; CMML; Myeloproliferative Disorders; Refractory Anemia with Excess of Blasts; RAEB-t; RAEB; Hum-195/rGel

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  Dose-limiting toxicity considered to have occurred when (1) \>grade 2 extramedullary toxicity possibly related to HuM195/rGel (except nausea, vomiting or diarrhea unless uncontrolled by optimal management, or electrolyte abnormalities unless clinically significant or not correctable after optimal replacement) is observed or (2) \>42 days from day 1 of therapy elapse before return of neutrophil count to \>500 and platelet count to \>25,000 in absence of leukemia (i.e., with a normal or hypercellular bone marrow with \<5% blasts).

  Continuous assessment of safety throughout entire study period and determination of dose-limiting toxicities at end of two week evaluation period (4 weeks from start of therapy).

Study Arms (1)

HuM195/rGel

EXPERIMENTAL

HuM195/rGel starting Dose = 3 mg/m\^2 twice weekly for 2 weeks.

Drug: Hum-195/rGel

Interventions

Hum-195/rGel DRUG

Starting Dose = 3 mg/m\^2 twice weekly for 2 weeks.

HuM195/rGel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed or refractory acute myelogenous leukemia (AML), Refractory anemia with excess blasts in transformation (RAEB-t), Refractory Anemia with Excess Blasts (RAEB), or chronic myelomonocytic leukaemia (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:
• P. vera,
• myelofibrosis
• essential thrombocytopenia with \>5% blasts in the blood or bone marrow.
• Male or female 18 yrs of age or older who have provided written informed consent
• Tumor cells must be = or \> 80% CD33 positive by flow cytometry
• 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
• White blood count (WBC) count \<10,000/ml for AML, MDS, and myeloproliferative disorders and up to 30,000 for accelerated CML
• No cytotoxic chemotherapy for the two weeks prior to entering the study
• No evidence of residual toxic effects grade 2 or higher from prior chemotherapy
• 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
• Creatinine - Patients should have values = or \< 1.5 times the upper limit of laboratory normal values
• 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
• Cardiac function - Patients with cardiovascular disease should be \< New York Heart Association (NYHA) classification III
• Pulmonary function - O2 saturation should be = or \> 92% without exogenous O2 administered.

You may not qualify if:

• Women who are pregnant or lactating

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson's Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Chronic; Myeloproliferative Disorders; Anemia, Refractory, with Excess of Blasts

Interventions

HuM195-gelonin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Refractory; Anemia; Myelodysplastic Syndromes

Study Officials

• Jorge Cortes, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2002
• First Posted: May 27, 2002
• Study Start: May 1, 1999
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)