NCT00003340

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1997

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

August 16, 2004

Completed
Last Updated

May 2, 2014

Status Verified

May 1, 2014

Enrollment Period

2.3 years

First QC Date

November 1, 1999

Last Update Submit

May 1, 2014

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia

Interventions

cyclophosphamideDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Interventions

CyclophosphamideTopotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Carole Miller, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 16, 2004

Study Start

November 1, 1997

Primary Completion

February 1, 2000

Study Completion

February 1, 2000

Last Updated

May 2, 2014

Record last verified: 2014-05

Locations

US(1)