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Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer Clinical research trials and Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer clinical trial. Subjects frequently get the best healthcare possible for their Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer  Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
For Condition: childhood acute myeloid leukemia and other myeloid malignancies,adult acute myeloid leukemia,Chronic Myelomonocytic Leukemia,Chronic Myelogenous Leukemia,myelodysplastic and myeloproliferative disease,atypical chronic myeloid leukemia
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in treating patients who have advanced myeloid cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies. - Determine the antileukemic effects of this treatment in this patient population. - Determine the toxicity of this treatment in this patient population. - Determine the complete remission rate of patients treated with this treatment regimen. OUTLINE: This is a dose escalation study of bismuth Bi 213 monoclonal antibody M195 (Bi213 MOAB M195). Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD. Patients are followed twice weekly for 4 weeks and then monthly for 3 months. PROJECTED ACCRUAL: A total of 3-39 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Pathologically confirmed acute myeloid leukemia (AML) meeting one of the following criteria: - Newly diagnosed AML, over age 60, and not eligible for higher priority protocols - Newly diagnosed AML and unable to receive anthracycline-containing or high-dose cytarabine-containing regimens - AML in relapse - AML refractory to two courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy - Chronic myelogenous leukemia in accelerated phase or myeloid blast crisis - Refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia - More than 25% of bone marrow blasts must be CD33 positive - Not a candidate for immediate bone marrow transplantation with a HLA-compatible donor - No active CNS leukemia PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2 mg/dL (unless due to leukemia or Gilbert's disease) - Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN Renal: - Creatinine less than 2 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No New York Heart Association class III or IV cardiac disease Pulmonary: - No pulmonary disease Other: - No detectable antibodies to monoclonal antibody M195 - No serious active uncontrolled infection - No other concurrent active malignancy requiring therapy - No other serious or life-threatening conditions that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior biologic therapy and recovered Chemotherapy: - See Disease Characteristics - Prior hydroxyurea allowed if discontinued before study treatment - At least 3 weeks since other prior chemotherapy and recovered Endocrine therapy: - Not specified Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephJurcic, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Joseph Jurcic 212-639-2955
Additional Information:
Study ID Numbers: CDR0000068549; NCI-H01-0071,MSKCC-00117
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014495
Other Myelodysplastic And Myeloproliferative Disease Studies:
1. Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
2. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
3. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
4. Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
5. Radiolabeled Monoclonal Antibody Therapy and Etoposide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Myelodysplastic Syndrome or Refractory Leukemia
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
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