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| Sponsored by: |
Drexel University College of Medicine |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003619 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Isotretinoin may help cancer cells develop into normal white blood cells.
PURPOSE: Phase I/II trial of topotecan, fludarabine, cytarabine, and filgrastim followed by peripheral stem cell transplantation or isotretinoin in treating patients who have acute myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Thrombocytopenia |
Biological: filgrastim Dietary Supplement: vitamin E Drug: busulfan Drug: cytarabine Drug: etoposide Drug: fludarabine phosphate Drug: isotretinoin Drug: topotecan hydrochloride Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Combination Study of Topotecan, Fludarabine, Cytosine Arabinoside and G-CSF (T-FLAG) Induction Therapy in Patients With Poor Prognosis AML, MDS and Relapsed/Refractory ALL Followed by Maintenance of Either PBSC Transplant or 13 Cis-Retinoic Acid |
| Study Start Date: | February 1998 |
OBJECTIVES: I. Determine the safety of topotecan in combination with fludarabine, cytarabine, and filgrastim (FLAG) in patients with poor prognosis acute myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic leukemia. II. Determine the maximum tolerated dose of topotecan in the FLAG regimen in these patients. III. Assess the complete remission rates in patients treated with this regimen.
OUTLINE: Patients with complete response proceed to further therapy according to age. 65 and under: Patients receive etoposide by IV continuously for 5 days, cytarabine IV over 2 hours every 12 hours for 4 days, and filgrastim (G-CSF) subcutaneously. Peripheral blood stem cells (PBSC) are then harvested. Patients then receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 10 hours on day -3. PBSC are reinfused on day 0. Over 65: Patients receive oral isotretinoin and vitamin E daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every month for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 3-4 years.
Eligibility| Ages Eligible for Study: | 19 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven poor prognosis acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or recurrent/refractory acute lymphocytic leukemia, including: Myelodysplastic syndrome (MDS) stages B and C Refractory anemia, refractory anemia with ringed sideroblasts, or refractory anemia with excess blasts (between 5% and 20% myeloblasts) MDS with increased erythroblasts or monocytoblasts of no greater than 20% MDS in transformation (between 20% to 30% myeloblasts) or acute nonlymphoblastic leukemia (at least 30% myeloblasts) Chronic myelomonocytic leukemia Poor prognosis refractory or recurrent acute myeloid leukemia after complete response Secondary or therapy related AML or MDS AML blastic crisis of chronic myelogenous leukemia or other myeloproliferative disorders such as polycythemia vera, essential thrombocytopenia, or agnogenic myeloid metaplasia
PATIENT CHARACTERISTICS: Age: 19 to 90 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT less than 2.0 times upper limit of normal Renal: Normal serum creatinine Cardiovascular: No congestive heart failure No symptomatic ischemic heart disease Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No uncontrolled infection No poorly controlled diseases (e.g., diabetes, systemic lupus erythematosus) No history of psychiatric disorders No other malignancies within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No concurrent severe medical problems No history of allergic reaction to topotecan and its derivatives
PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent immunotherapy Chemotherapy: No prior topotecan At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other investigational drugs within 30 days of study No other concurrent investigational therapy except for basal cell skin cancer
Contacts and Locations| United States, Pennsylvania | |
| Medical College of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19129 | |
| Medical College of Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19129 | |
| Study Chair: | Emmanuel C. Besa, MD | Drexel University College of Medicine |
More Information
| Study ID Numbers: | CDR0000066698, AUH-MCP-70612-01, AUH-MCP-70612-02P, NCI-V98-1485 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003619 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia polycythemia vera chronic idiopathic myelofibrosis refractory anemia |
refractory anemia with ringed sideroblasts refractory anemia with excess blasts chronic myelomonocytic leukemia secondary acute myeloid leukemia previously treated myelodysplastic syndromes secondary myelodysplastic syndromes thrombocytopenia |
|
Polycythemia Anti-Infective Agents Blast Crisis Chronic Myelomonocytic Leukemia Tocopherol Refractory Anemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Thrombocytopenia Acute Myeloid Leukemia, Adult Neoplasm Metastasis Etoposide Tocopherol acetate Immunoproliferative Disorders |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Platelet Disorders Myeloproliferative Disorders Leukemia, Myeloid Alpha-Tocopherol Vitamin E Tretinoin Chronic Myelogenous Leukemia Fludarabine Topotecan Antimetabolites Leukemia, Lymphoid Immunologic Factors |
|
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Leukemia Preleukemia Thrombocytopenia Pathologic Processes Therapeutic Uses |
Syndrome Isotretinoin Dermatologic Agents Cytarabine Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Disease Immune System Diseases Hematologic Diseases Blood Platelet Disorders Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid |
