- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003340
Cyclophosphamide Plus Topotecan in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in treating patients who have refractory or relapsed acute myelogenous leukemia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Evaluate the efficacy of cyclophosphamide followed by topotecan in patients with relapsed or refractory acute myelogenous leukemia. II. Confirm safety and tolerability of this combination on this schedule in these patients.
OUTLINE: Patients receive cyclophosphamide intravenously over 1 hour on day 1 followed by topotecan as a continuous 120 hour infusion starting 12 hours after completion of cyclophosphamide. Treatment may be repeated every 3-6 weeks for at least 2 courses.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Oncology Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia by bone marrow aspirate or biopsy Clear evidence of relapse or residual disease with greater than 5% blasts on bone marrow examination or greater than 30% peripheral blasts No active CNS leukemia Not eligible for potentially curative allogeneic or autologous bone marrow transplantation without further surgery Must have failed to achieve a complete remission with conventional chemotherapy (cytarabine based) or have relapsed within 12 months after initial remission
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.6 mg/dL (unless due to disease) Renal: Creatinine less than 1.6 mg/dL (unless due to disease) No prior hemorrhagic cystitis Other: Not pregnant Fertile patients must use effective contraception No active uncontrolled infection
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Must have recovered from prior radiotherapy Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Carole Miller, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Cyclophosphamide
- Topotecan
Other Study ID Numbers
- J9736 CDR0000066314
- JHOC-97100102
- J-9736
- NCI-G98-1435
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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