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| Sponsored by: |
M.D. Anderson Cancer Center |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038051 |
Purpose
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.
Optional Procedures: Some patients will be asked to give extra blood samples. These samples will be used to help doctors learn how the body excretes the immunotoxin.
| Condition | Intervention | Phase |
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Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myeloproliferative Disorders Anemia, Refractory, With Excess of Blasts |
Drug: Hum-195/rGel |
Phase I |
| MedlinePlus related topics: | Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I Evaluation of the Anti-CD-33 Immunotoxin Hum-195/rGel in Patients With Advanced Myeloid Malignancies |
| Estimated Enrollment: | 36 |
| Study Start Date: | June 1999 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
HuM195/rGel
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Drug: Hum-195/rGel
Starting Dose = 3 mg/m2 twice weekly x 2 weeks.
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Before therapy, all patients will be asked about their medical history, a physical exam will be performed, and vital signs will be taken. A chest X-ray, ECG, complete blood count, serum chemistry and urinalysis will be performed as well. During the study period, we will obtain samples to measure blood counts, serum chemistry, pharmacokinetics and anti-drug antibodies. A bone marrow sample will also be obtained on study day 28.
Patients will receive four injections of the immunotoxin. The immunotoxin is designed to selectively destroy myeloid leukemia cells. The injections will be given through a vein twice weekly for two weeks. Patients will then be evaluated twice weekly for the next two weeks. If there has been improvement in the leukemia, or if there have been no serious side effects of treatment, patients will then receive a second course of immunotoxin injections. These will again be given twice weekly for two weeks. Depending on the effectiveness against leukemia and the side effects, patients may receive maintenance treatment. This would also consist of two weekly injections given for two weeks followed by two weeks of observation. Maintenance therapy may continue for up to four months for partial response and up to two months for complete response.
This is an investigational study. Up to 36 patients will take part in this study.
Optional Procedures: Extra blood (1 tube or about 2 tablespoons) marrow samples will be taken at day 28 of study.
You do not have to agree to take part in the optional procedures in order to receive treatment on this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1) Women who are pregnant or lactating.
Contacts and Locations| Contact: Jorge Cortes, MD | 713-792-3522 |
| United States, Texas | |||||
| U.T.M.D. Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Principal Investigator: Jorge Cortes, MD | |||||
| M.D. Anderson Cancer Center |
| Principal Investigator: | Jorge Cortes, MD | U.T.M.D. Anderson Cancer Center |
More Information
M.D. Anderson's Website 
  |
| Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Jorge Cortes, M.D./Professor ) |
| Study ID Numbers: | DM98-342 |
| First Received: | May 24, 2002 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00038051 |
| Health Authority: | United States: Food and Drug Administration |
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