Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent acute leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Neutropenia |
Biological: filgrastim Drug: carboplatin Drug: topotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | PHASE I STUDY OF CONTINUOUS INFUSION CARBOPLATIN AND TOPOTECAN IN THE TREATMENT OF RELAPSED ACUTE LEUKEMIA AND BLAST CRISIS CHRONIC MYELOGENOUS LEUKEMIA |
| Study Start Date: | October 1995 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Estimate the maximum tolerated dose of carboplatin plus topotecan given as a 5-day continuous infusion in patients with recurrent acute lymphocytic or myeloid leukemia or accelerated or blastic phase chronic myelogenous leukemia.
- Assess the toxicity of this regimen in these patients.
- Gather preliminary information on the activity of this regimen in these patients.
- Examine the pharmacokinetics of topotecan when administered concurrently with carboplatin.
OUTLINE: This is a dose escalation study of topotecan. Patients are stratified according to prior bone marrow transplant (BMT) (yes vs no).
- Induction: Patients receive carboplatin and topotecan IV 3 times a day on days 1-5. Patients may also receive filgrastim (G-CSF) beginning on day 7 or 14. Retreatment is based on results of marrow exam on day 10-14. Patients with less than 5% blasts undergo a second marrow exam upon blood count recovery or on day 26-30, whichever is earlier. Patients with at least 5% blasts after day 21 receive one more course, in the absence of unacceptable toxicity and at the discretion of the investigator. Patients with no greater than 5% blasts begin G-CSF if blood counts are not recovered, then proceed to consolidation.
Cohorts of 1-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose limiting toxicity. Patients with prior BMT will not be entered at any level until 3-6 patients with no prior BMT tolerate that level.
- Consolidation (begins around day 42 of last Induction course): Patients with ALL/AML in complete remission (CR) or CML in chronic phase receive 2 additional courses (same doses) 6-8 weeks apart.
Patients experiencing a relapse after CR lasting at least 6 months may receive additional treatment.
PROJECTED ACCRUAL: A total of 15-20 patients without and 2-20 patients with prior bone marrow transfer will be accrued for this study over 2-2.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Acute lymphocytic or myeloid leukemia (ALL or AML) in 1 of the following categories:
- Failed to achieve a complete response (CR) with initial induction regimen
- First relapse within 1 year of initial CR
- Failed re-induction therapy at first relapse
- Second relapse after no more than 2 different induction regimens
Relapse defined as more than 10% blasts in marrow or circulating blasts in peripheral blood and either:
- Symptoms of recurrence (e.g., B symptoms)
- Evidence of impending marrow failure (i.e., cytopenias) OR
- Chronic myelogenous leukemia in accelerated or blastic phase after no more than 1 prior induction regimen
- No HLA-identical sibling marrow donor or patient ineligible for allogeneic marrow transplantation
No clinical symptoms of CNS leukemia
- Patients with history of CNS leukemia must have pretreatment lumbar puncture demonstrating absence of active CNS disease
- No active CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 4 weeks
Hematologic:
- Not applicable
Hepatic:
- Bilirubin less than 2 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No congestive heart failure
- No poorly controlled arrhythmia
- No myocardial infarction within the past 3 months
Other:
- No active infection
- No other serious medical condition that would prevent compliance
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
- At least 24 hours since prior hydroxyurea for impending leukostasis
- No concurrent hydroxyurea glucocorticoids
- Recovered from prior chemotherapy
Endocrine therapy:
- At least 24 hours since prior glucocorticoids for impending leukostasis
- At least 7 days since prior amphotericin or aminoglycosides
- No concurrent glucocorticoids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent aminoglycoside antibiotics
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Scott Harold Kaufmann, M.D. Ph.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002693 History of Changes |
| Other Study ID Numbers: | CDR0000064447, U01CA069912, P30CA015083, 958101 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mayo Clinic:
|
recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia |
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia neutropenia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neutropenia Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Agranulocytosis Leukopenia Leukocyte Disorders Carboplatin |
Topotecan Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013