NCT00100477

Brief Summary

The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 1998

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2001

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2004

Completed
Last Updated

September 25, 2013

Status Verified

September 1, 2013

Enrollment Period

2.4 years

First QC Date

December 30, 2004

Last Update Submit

September 24, 2013

Conditions

Non-Hodgkin's LymphomaLeukemia

Keywords

Multiple MyelomaLymphomaLeukemiaEtoposideDrug TherapyClinical Trials

Study Arms (1)

Arm 1

OTHER
Drug: TopotecanDrug: MitozantroneDrug: Etoposide

Interventions

TopotecanDRUG
Arm 1
MitozantroneDRUG
Arm 1
EtoposideDRUG
Arm 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in the following disease categories will be considered eligible for this study:
  • Any acute leukemia beyond an initial attempt to induce a remission or after relapse
  • Chronic Myelogenous Leukemia in Blast Phase
  • Refractory Multiple Myeloma
  • Refractory non-Hodgkin's and Hodgkin's Lymphoma
  • Patients must be more than 14 days beyond prior myelotoxic chemotherapy
  • Several other eligibility criteria apply.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemiaMultiple MyelomaLymphoma

Interventions

TopotecanMitoxantroneEtoposide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesGlycosidesCarbohydrates

Study Officials

  • Mark Mainwaring

    North Florida/South Georgia Veterans Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2004

First Posted

December 31, 2004

Study Start

August 1, 1998

Primary Completion

January 1, 2001

Study Completion

June 1, 2001

Last Updated

September 25, 2013

Record last verified: 2013-09

Locations

US(1)