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Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes Clinical research trials and Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes. Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes  Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes
Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes
For Condition: myelodysplastic and myeloproliferative disease,secondary acute myeloid leukemia,adult acute myeloid leukemia,Chronic Myelogenous Leukemia,childhood acute myeloid leukemia and other myeloid malignancies,atypical chronic myeloid leukemia
Status: Recruiting
Sponsor(s): Ireland 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. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining fludarabine, carboplatin, and topotecan with thalidomide in treating patients who have relapsed or refractoryacute myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes.
Details: OBJECTIVES: - Determine the response rate of patients with relapsed/refractory or high-risk acute myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes treated with fludarabine, carboplatin, topotecan, and thalidomide. - Determine the non-hematologic toxicity profile and time to hematopoietic recovery in patients treated with this regimen. - Determine the effects of this regimen on changes in biologic parameters that may predict response in these patients. - Correlate bone marrow microvascular density before and after treatment with response in these patients. - Determine the prognostic value of pretreatment plasma and serum levels of vascular endothelial growth factor (VEGF) and/or the modulation of serum levels of VEGF during treatment in predicting response in these patients. OUTLINE: Patients are stratified according to diagnosis (previously untreated acute leukemia vs other). Patients receive fludarabine IV over 5-10 minutes and carboplatin IV over 24 hours on days 1-5 followed by topotecan IV continuously over 72 hours. Patients receive oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity. Patients with residual disease on day 16-18 may receive a second course of chemotherapy as above. Patients who achieve remission may receive a third course of chemotherapy as above as consolidation beginning 4-8 weeks after completion of prior chemotherapy. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Acute myeloid leukemia meeting 1 of the following criteria: - Previously untreated and not a candidate for anthracycline-based chemotherapy - In first or second relapse or refractory - Secondary to chemotherapy or an antecedent hematologic disorder and treated with no more than 1 prior intensive induction regimen - Chronic myelogenous leukemia in blast crisis at diagnosis or after prior imatinib mesylate - Myelodysplastic syndromes (MDS) - Refractory anemia with excess blasts (RAEB) or RAEB in transformation - Must meet at least 1 of the following criteria: - Absolute neutrophil count no greater than 500/mm^3 - Platelet or red cell transfusion-dependent after no more than 1 prior intensive induction chemotherapy - Acute promyelocytic leukemia - t(15, 17) - Failed prior treatment with tretinoin and arsenic - Relapsed disease at least 3 months after prior autologous stem cell transplantation - No active CNS leukemia PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-3 Life expectancy - At least 8 weeks Hematopoietic - See Disease Characteristics Hepatic - Bilirubin no greater than 2.0 mg/dL - AST and ALT less than 3 times upper limit of normal Renal - Creatinine clearance at least 50 mL/min Cardiovascular - Ejection fraction at least 40% - No poorly controlled cardiac disease Pulmonary - No poorly controlled pulmonary disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile female patients must use 1 highly effective and 1 additional method of contraception for 4 weeks before, during, and for at least 4 weeks after study - Male patients must use effective contraception during and for 4 weeks after study - Willing and able to comply with the System for Thalidomide Education and Prescribing Safety (STEPS) program - HIV negative - No poorly controlled infection - No other active malignancy - No severe peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - Prior thalidomide allowed for MDS - At least 5 days since prior hematopoietic growth factors - At least 2 weeks since prior biologic therapy - No prior allogeneic bone marrow transplantation Chemotherapy - See Disease Characteristics - At least 24 hours since prior hydroxyurea Endocrine therapy - At least 24 hours since prior corticosteroids Radiotherapy - Not specified Surgery - Not specified Other - At least 2 weeks since prior cytotoxic anticancer therapy - Prior amifostine allowed for MDS
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaCooper, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Brenda Cooper 216-844-3213
Additional Information:
Study ID Numbers: CDR0000269343; CELGENE-CWRU-1902,CWRU-1902
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053287
Other Secondary Acute Myeloid Leukemia Studies:
1. MS-275 in Treating Patients With Hematologic Cancer
2. VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome
3. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
4. Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
5. Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome
Related Studies:
Other secondary acute myeloid leukemia Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes
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