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Clinical Trials/NCT00251368
NCT00251368CompletedPhase 1

Multicenter Study of 9-AC in Refractory Leukemia

Dana-Farber Cancer Institute4 sites in 1 country52 target enrollmentStarted: January 1995Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
52
Locations
4
Primary Endpoint
To evaluate the toxicity and maximum tolerated dose of 9-AC administered as a 72 hour infusion in patients with relapsed/refractory leukemia.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

  • The treatment patients will receive involves a continuous infusion of 9-AC intravenously for a 72 hour period. Since we are unsure of the safest and most effective dose, successive groups of 4-7 patients will receive larger doses of this drug until the largest dose given safely is established.
  • Prior to the start of therapy a bone marrow aspirate and biopsy will be taken for diagnostic and research purposes. A bone marrow exam will be repeated at 48 hours in order to determine the effects of 9-AC on leukemic cells in the bone marrow. A bone marrow scan will also be performed 14 days after the start of therapy to assess response.
  • Frequent blood testing will be done throughout treatment, including blood samples to determine the levels of the 9-AC in the blood.
  • Treatment could be stopped prematurely if any of the following occur: 1) drug causes severe side effects, 2) the drug does not control the leukemia, or 3) the doctors or the patient feel that it is no longer in the patients best interest to receive this therapy.
  • Approximately 7 days after the conclusion of the 9-AC infusion, it is likely that the patient's blood counts will be low and will require support with antibiotics, red cell transfusions and platelet transfusions.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •18 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Years

Secondary Outcomes

  • To analyze the pharmacokinetics in these patients.(years)

Investigators

Sponsor Class
Other

Study Sites (4)

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Multicenter Study of 9-Aminocamptothecin... | Clinical Trial