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Multicenter Study of 9-AC in Refractory Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelocytic, Acute, Acute Lymphocytic Leukemia

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Trial Information

Multicenter Study of 9-AC in Refractory Leukemia


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Years

Principal Investigator

Richard Stone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

94-115

NCT ID:

NCT00251368

Start Date:

January 1995

Completion Date:

September 2007

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • Acute Lymphocytic Leukemia
  • leukemia
  • 9-Aminocamptothecin
  • AML
  • ALL
  • refractory leukemia
  • relapsed leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HosptialBoston, Massachusetts  02114