Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
|ClinicalTrials.gov Identifier: NCT00012376|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: bryostatin 1 Biological: sargramostim Other: laboratory biomarker analysis Other: pharmacological study||Phase 1|
I. To determine the maximally tolerated dose of continuous intravenous infusion bryostatin-1 when given in combination with GM-CSF.
II. To describe and quantify the frequency of toxicity of the combination of continuous intravenous infusion bryostatin-1 and subcutaneously administered GM-CSF.
I. To describe the impact of the combination of bryostatin-1 and GM-CSF on the differentiation and cell cycle distribution of myeloid cells in vivo.
II. To describe the impact of the combination of bryostatin-1 and GM-CSF on T lymphocyte populations.
III. To assess the pharmacokinetics of continuous infusion bryostatin-1.
OUTLINE: This is a dose-escalation study of bryostatin 1.
Patients receive bryostatin 1 IV continuously and sargramostim (GM-CSF) subcutaneously once daily on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with disease stabilization or improvement may continue treatment for up to 12 courses.
Cohorts of 2 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 30% of patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose Finding Study of Bryostatin-1 and GM-CSF in Refractory Myeloid Malignancies|
|Study Start Date :||March 2001|
|Primary Completion Date :||January 2010|
Experimental: Treatment (bryostatin 1 and sargramostim)
Patients receive bryostatin 1 IV continuously and GM-CSF subcutaneously once daily on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with disease stabilization or improvement may continue treatment for up to 12 courses.
Drug: bryostatin 1
Other Names:Biological: sargramostim
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studies
- MTD defined as the dose at which the CRM estimates that 30% of patients will experience dose-limiting toxicity (DLT) assessed using CTC version 2.0 [ Time Frame: 56 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012376
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287-8936|
|Principal Investigator:||B. Smith||Johns Hopkins University|