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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053287 |
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 refractory acute myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: carboplatin Drug: fludarabine phosphate Drug: thalidomide Drug: topotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Fludarabine, Carboplatin, and Topotecan With Thalidomide for Patients With Relapsed/Refractory or High Risk Acute Myelogenous Leukemia, Chronic Myeloid Leukemia and Advanced Myelodysplastic Syndromes |
Estimated Enrollment: | 40 |
Study Start Date: | September 2002 |
OBJECTIVES:
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.
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:
Acute myeloid leukemia meeting 1 of the following criteria:
Myelodysplastic syndromes (MDS)
Must meet at least 1 of the following criteria:
Acute promyelocytic leukemia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Brenda W. Cooper, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000269343, CASE-CWRU-1902, CELGENE-CWRU-1902, CASE-1902 |
Study First Received: | January 27, 2003 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00053287 |
Health Authority: | United States: Federal Government |
adult acute promyelocytic leukemia (M3) refractory anemia with excess blasts in transformation refractory anemia with excess blasts de novo myelodysplastic syndromes recurrent adult acute myeloid leukemia secondary acute myeloid leukemia untreated adult acute myeloid leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
previously treated myelodysplastic syndromes secondary myelodysplastic syndromes atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
Blast Crisis Thalidomide Precancerous Conditions Chronic myelogenous leukemia Refractory anemia Leukemia, Myeloid, Acute Leukemia Preleukemia Anemia, Refractory Leukemia, Promyelocytic, Acute Neoplasm Metastasis Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia Myelodysplastic syndromes |
Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplastic Syndromes Myelodysplasia Acute promyelocytic leukemia Anemia Myeloproliferative Disorders Acute myelogenous leukemia Carboplatin Fludarabine monophosphate Leukemia, Myeloid Recurrence Myelodysplastic myeloproliferative disease Leukemia, Myelogenous, Chronic, BCR-ABL Positive Fludarabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Neoplasms Pathologic Processes Syndrome Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |