Expired Study
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Rochester, Minnesota 55905


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.

Study summary:

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.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia

Official Title:


Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Scott H. Kaufmann, MD, PhD
Study Chair
Mayo Clinic

Study Dates

Start Date:October 1995
Completion Date:April 2006
Completion Type:Actual
Primary Completion Date:April 2006
Primary Completion Type:Actual
Verification Date:August 2011
Last Changed Date:August 2, 2011
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Intervention Type:Drug
Intervention Type:Drug
Name:topotecan hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Kaufmann S, Letendre L, Litzow M, et al.: Phase I study of continuous infusion (CI) topotecan (TPT) and carboplatin (CBDCA) for relapsed or refractory acute leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A107, 1998.

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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