Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
NCT00012376 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2013-01-09
Summary
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Phase I trial to study the effectiveness of bryostatin 1 combined with sargramostim in treating patients who have refractory myeloid cancer
Conditions
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Blastic Phase Chronic Myelogenous Leukemia
- Chronic Myelomonocytic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- Paroxysmal Nocturnal Hemoglobinuria
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Myeloid Leukemia
- Refractory Anemia
- Refractory Anemia With Ringed Sideroblasts
- Relapsing Chronic Myelogenous Leukemia
- Thrombocytopenia
- Untreated Adult Acute Myeloid Leukemia
Interventions
- DRUG
-
bryostatin 1
Given IV
- BIOLOGICAL
-
sargramostim
Given subcutaneously
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
pharmacological study
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
B. Smith · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-03-31
- Primary Completion
- 2010-01-31
Countries
- United States
Study Locations
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