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| Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012376 |
Purpose
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 combined with sargramostim in treating patients who have refractory myeloid cancer.
| Condition | Intervention | Phase |
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: bryostatin 1 Drug: sargramostim |
Phase I |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| ChemIDplus related topics: | Sargramostim Granulocyte-macrophage colony-stimulating factor Bryostatin 1 |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Dose Finding Study of Bryostatin-1 and GM-CSF in Refractory Myeloid Malignancies |
| Study Start Date: | March 2001 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Myelodysplastic syndromes (MDS) by bone marrow aspiration and/or biopsy indicating primary refractory leukopenia or thrombocytopenia with morphologic features of MDS
Relapsed acute myeloid leukemia (AML) by bone marrow aspiration or biopsy
Newly diagnosed AML
Accelerated or blastic phase chronic myelogenous leukemia (CML)
Symptomatic paroxysmal nocturnal hemoglobinuria (PNH) associated with disease
No active CNS disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Maryland | |||||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
| Baltimore, Maryland, United States, 21231 | |||||
| Sidney Kimmel Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | B. Douglas Smith, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068517, JHOC-J0051, NCI-951 |
| First Received: | March 3, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012376 |
| Health Authority: | United States: Federal Government |
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