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FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma Clinical research trials and FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma. FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma clinical trial. Participants typically obtain the most effective healthcare available for their FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma  FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
For Condition: adult acute myeloid leukemia,Chronic Myelomonocytic Leukemia,adult non-Hodgkin's lymphoma,childhood acute myeloid leukemia and other myeloid malignancies,myelodysplastic and myeloproliferative disease,atypical chronic myeloid leukemia
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering 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. PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the pattern of adverse clinical experience in patients with myelodysplastic syndrome, acute myeloid leukemia, or intermediate-grade or follicular non-Hodgkin's lymphoma treated with FR901228. - Determine the disease response in patients treated with this drug. - Determine the pharmacokinetic and pharmacodynamic correlates of this drug, including measurement of serum plasma levels, H3 and H4 acetylation, apoptosis induction, differentiation, and multidrug-resistant (MDR) phenotype expression in these patients. OUTLINE: Patients receive FR901228 IV over 4 hours on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly. PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Histologically confirmed refractory or relapsed acute myeloid leukemia (AML) - Failed anthracycline-based chemotherapy - Ineligible for or refused allogeneic stem cell transplantation - Elderly patients with newly diagnosed AML - Ineligible for or refused standard chemotherapy - Histologically confirmed high-risk myelodysplastic syndromes - Eligible subtypes include: - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - Ineligible for or refused allogeneic bone marrow transplantation - Histologically confirmed intermediate-grade non-Hodgkin's lymphoma (NHL) - Relapsed after high-dose therapy OR - Ineligible for allogeneic or autologous stem cell transplantation - Evaluable lesions by radiologic study or physical examination - Histologically confirmed follicular NHL - Progressed after anthracycline-based chemotherapy and rituximab - Evaluable lesions by radiologic study or physical examination NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome) - SGOT and SGPT less than 2 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular - Cardiac ejection fraction greater than 50% - No New York Heart Association class III or IV heart disease that would make it difficult to assess patient during study participation - No significant prior heart disease - No significant prior secondary or tertiary heart block - No significant prior atrial or ventricular arrhythmia requiring therapeutic intervention or antiarrhythmics for rate control Pulmonary - No severe debilitating pulmonary disease that would make it difficult to assess patient during study participation Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study participation - No other concurrent active malignancy except basal cell skin cancer - No other concurrent significant co-morbidity that would make it difficult to assess patient during study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 2 weeks since prior epoetin alfa or filgrastim (G-CSF) - At least 4 weeks since prior cytokines - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior systemic chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VirginiaKlimek, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Stephen Nimer 212-639-7871
Additional Information:
Study ID Numbers: CDR0000069473; NCI-1715,MSKCC-00116
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042822
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1. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
2. Chemotherapy in Treating Children With Down Syndrome Plus Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
3. Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes
4. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
5. FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
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FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
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