NCT00251368

Brief Summary

The purpose of this study is to evaluate the side effects of 9-Aminocamptothecin (9-AC) and to determine the best dose which should be used to treat leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 1995

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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

January 1, 1995

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 10, 2011

Status Verified

March 1, 2011

Enrollment Period

12.7 years

First QC Date

November 8, 2005

Last Update Submit

March 9, 2011

Conditions

Leukemia, Myelocytic, AcuteAcute Lymphocytic Leukemia

Keywords

leukemia9-AminocamptothecinAMLALLrefractory leukemiarelapsed leukemia

Outcome Measures

Primary Outcomes (1)

  • To evaluate the toxicity and maximum tolerated dose of 9-AC administered as a 72 hour infusion in patients with relapsed/refractory leukemia.

    Years

Secondary Outcomes (1)

  • To analyze the pharmacokinetics in these patients.

    years

Interventions

9-Aminocamptothecin (9-AC)DRUG

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • AML or ALL in first or subsequent relapse, secondary AML, or CML in blastic phase
  • Central venous access
  • ECOG performance status of less than or equal to 2
  • Bilirubin \< 1.3
  • SGOT \< 2 x ULN
  • Alkaline phosphatase \< 2 x ULN
  • Creatinine \< 1.5

You may not qualify if:

  • Undergone bone marrow transplantation
  • Uncontrolled infection
  • Other active malignancy
  • HIV positivity
  • Serious medical or psychiatric illness
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia

Interventions

9-aminocamptothecin

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Richard Stone, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 10, 2005

Study Start

January 1, 1995

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

March 10, 2011

Record last verified: 2011-03

Locations

US(2)