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Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer Clinical research trials and Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer. Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer  Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
For Condition: adult acute myeloid leukemia,myelodysplastic and myeloproliferative disease,Chronic Myelogenous Leukemia,atypical chronic myeloid leukemia,childhood acute myeloid leukemia and other myeloid malignancies,Chronic Myelomonocytic Leukemia
Status: Recruiting
Sponsor(s): Sidney Kimmel 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. 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 refractorymyeloid cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of bryostatin 1 when administered with sargramostim (GM-CSF) in patients with refractory myeloid malignancies. - Determine the toxicity frequency of this regimen in these patients. - Determine the pharmacokinetics of bryostatin 1 in these patients. 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 1-14. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 - Refractory anemia (RA) and RA with ringed sideroblasts allowed provided transfusion dependent - No RA with 5q syndrome - Chronic myelomonocytic leukemia allowed - Failure to achieve remission after intensive chemotherapy allowed if received chemotherapy more than 1 month prior to study - Progression on other prior institutional trials including phenylbutyrate, tretinoin, or azacitidine allowed - Relapsed acute myeloid leukemia (AML) by bone marrow aspiration or biopsy - No acute promyelocytic leukemia - WBC less than 30,000/mm^3 and stable for at least 7 days - Unlikely to require cytotoxic therapy during study - Newly diagnosed AML - Previously untreated - Not a candidate for potentially curative intensive chemotherapy - Refused prior chemotherapy or deemed poor medical candidate for AML induction chemotherapy - Accelerated or blastic phase chronic myelogenous leukemia (CML) - Previously treated chronic phase CML allowed - At least 2 weeks since prior treatment for accelerated or blastic phase CML - Blast count less than 30,000/mm^3 and stable for at least 7 days - No lymphoid blast phase CML - Symptomatic paroxysmal nocturnal hemoglobinuria (PNH) associated with disease - Life-threatening complications of illness (e.g., abdominal, central vein or cerebral thromboses, active infections, or recurrent symptomatic hemolytic crises) with no other treatment options allowed - Not a candidate for potentially curative bone marrow transplantation - Stable bone marrow function for more than 10 days prior to study (no WBC doubling within this time period) - No active CNS disease - Negative cytology by lumbar puncture for suspected CNS disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 2 months Hematopoietic: - See Disease Characteristics - Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: - Bilirubin less than 1.6 mg/dL (unless secondary to hemolysis) - SGOT/SGPT less than 2 times upper limit of normal unless disease related (e.g., PNH or extramedullary disease) Renal: - Creatinine less than 2.0 mg/dL Cardiovascular: - No disseminated intravascular coagulation Pulmonary: - No evidence of pulmonary leukostasis Other: - No radiographic evidence of active infection - No untreated positive blood cultures - No intolerance to sargramostim (GM-CSF) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 2 weeks since prior hematopoietic growth factors for myeloid disorder - At least 2 weeks since prior biologic therapy (e.g., monoclonal antibodies) for myeloid disorder - Recovered from prior biologic therapy Chemotherapy: - See Disease Characteristics - At least 2 weeks since prior chemotherapy (except hydroxyurea for WBC greater than 10,000/mm^3) for myeloid disorder and recovered - No prior bryostatin 1 Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
B.Smith, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting B. Smith 410-614-5068
Additional Information:
Study ID Numbers: CDR0000068517; JHOC-J0051,NCI-951
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012376
Other Myelodysplastic And Myeloproliferative Disease Studies:
1. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
2. Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
3. Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
4. Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
5. Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
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