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Home > "M" Clinical Trials Conditions > MS-275 in Treating Patients With Hematologic Cancer  MS-275 in Treating Patients With Hematologic Cancer
MS-275 in Treating Patients With Hematologic Cancer
For Condition: atypical chronic myeloid leukemia,myelodysplastic and myeloproliferative disease,chronic leukemia,plasma cell neoplasm,acute 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. PURPOSE: Phase I trial to study the effectiveness of MS-275 in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine the toxic effects and pharmacokinetics of MS-275 in patients with poor-risk hematologic malignancy. - Determine if this drug induces changes in hematologic differentiation, in terms of changes in morphology, cell surface marker expression, and acetylation status in these patients. - Determine if this drug induces clinical response in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral MS-275 on days 1, 8, 15, and 22. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
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 acute myelogenous leukemia (AML) - Newly diagnosed de novo AML in patients over 60 years old with the following poor-risk features: - Antecedent hematologic disorder - Complex karyotype or other adverse cytogenetics - Stem cell immunophenotype - AML arising from myelodysplastic syndromes (MDS) - Secondary AML - Relapsed or refractory AML, including primary induction failure - Histologically confirmed MDS - Poor-risk, defined as: - International Performance Score at least 1.5 - More than 10% marrow blasts - Cytopenias in at least 2 lineages - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - Histologically confirmed acute lymphoblastic leukemia (ALL) - Newly diagnosed de novo ALL in patients over 60 years old with the following poor-risk features: - Complex karyotype or other adverse cytogenetics - Mixed lineage immunophenotype - Relapsed or refractory ALL, including primary induction failure - Histologically confirmed chronic myelogenous leukemia (CML) - CML in accelerated phase or blast crisis - Interferon-refractory CML in chronic phase - Histologically confirmed multiple myeloma (MM) - Relapsed or refractory, including prior autologous stem cell transplantation - Histologically confirmed acute promyelocytic leukemia - Prior treatment with tretinoin - Ineligible for arsenic trioxide - No evidence of active coagulopathy - Low-risk for developing clinically significant coagulopathy during study - Low tumor burden by marrow aspiration at time of relapse - No prior coagulation-related sequelae (deep vein thrombosis, pulmonary embolism, CNS thrombosis or bleed) - Failure after primary induction therapy or relapse after complete remission allowed if no more than 3 courses of prior induction/reinduction therapy - Not eligible for curative stem cell transplantation - No hyperleukocytosis with at least 50,000/mm^3 leukemic blasts - No active CNS leukemia - No plasma cell leukemia - No amyloidosis resulting in major organ dysfunction PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - No disseminated intravascular coagulation - No hyperviscosity Hepatic: - AST/ALT no greater than 2 times normal - Alkaline phosphatase no greater than 2 times normal - Bilirubin no greater than 1.5 times normal Renal: - Creatinine no greater than 1.5 times normal - No uncorrected hypercalcemia Cardiovascular: - See Disease Characteristics - LVEF at least 45% by MUGA or echocardiogram - No intrinsic impaired cardiac function, including: - Myocardial infarction within the past 3 months - Prior severe coronary artery disease - Cardiomyopathy - Congestive heart failure Other: - No active uncontrolled infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 1 week since prior growth factors (epoetin alfa, filgrastim [G-CSF], sargramostim [GM-CSF], interleukin [IL]-3, or IL-11) - At least 4 weeks since prior autologous stem cell transplantation - No prior allogeneic stem cell transplantation - No concurrent immunotherapy Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered - At least 24 hours since prior hydroxyurea or mercaptopurine for prevention of leukostasis - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 2 weeks since prior emergency radiotherapy to large soft tissue or lytic bony lesions for MM - No concurrent radiotherapy Surgery: - Not specified Other: - No other concurrent investigational or commercially-available antitumor therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithKarp, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Judith Karp 410-502-7726
Additional Information:
Study ID Numbers: CDR0000068574; NCI-2791,MSGCC-0050,JHOC-J0253
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015925
Other Plasma Cell Neoplasm Studies:
1. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
2. Bevacizumab in Treating Patients With Myelodysplastic Syndrome
3. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
4. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
5. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
Related Studies:
Other plasma cell neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
MS-275 in Treating Patients With Hematologic Cancer
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