Trials / Completed
CompletedNCT00012376
Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
Dose Finding Study of Bryostatin-1 and GM-CSF in Refractory Myeloid Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
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
| Type | Name | Description |
|---|---|---|
| DRUG | bryostatin 1 | Given IV |
| BIOLOGICAL | sargramostim | Given subcutaneously |
| OTHER | laboratory biomarker analysis | Correlative studies |
| OTHER | pharmacological study | Correlative studies |
Timeline
- Start date
- 2001-03-01
- Primary completion
- 2010-01-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00012376. Inclusion in this directory is not an endorsement.