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Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia


Phase 1/Phase 2
15 Years
N/A
Open (Enrolling)
Both
Acute Lymphocytic Leukemia

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Trial Information

Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia


This is a Phase I/II, multi-center, open-label, dose escalation, MTD study of liposomal
annamycin in refractory or relapsed ALL patients. Enrollment will occur in cohorts of
approximately 3 patients with 10 additional patients enrolled at the MTD. The liposomal
annamycin doses will be escalated in sequential cohorts. Four dose levels of liposomal
annamycin are planned: 190, 230, 280, and 310 mg/m2/day.


Inclusion Criteria:



- Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia)

- Age greater than or equal to 15 years

- No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of
study drug and recovered from toxic side effects of that therapy, unless treatment is
indicated due to progressive disease.

- No investigational therapy within 4 weeks of first dose of study drug

- ECOG performance status (PS) 0 to 2.

- Adequate liver function

- Adequate renal function

- Signed informed consent

Exclusion Criteria:

- Concommitant therapy that includes other chemotherapy that is or may be active
against ALL (except central nervous system [CNS] therapy)

- Any condition which in the opinion of the investigator, places the subject at
unacceptable risk if he/she were to participate in the study.

- Cardiac ejection fraction less than 40%

- Clinically relevant serious co-morbid medical conditions.

- Pregnant, lactating or not using adequate contraception.

- Known allergy to doxorubicin or anthracyclines.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety and tolerability of L-Annamycin

Outcome Time Frame:

8 months

Safety Issue:

Yes

Principal Investigator

Gary Jacob, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Callisto Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CP-103

NCT ID:

NCT00271063

Start Date:

October 2005

Completion Date:

April 2008

Related Keywords:

  • Acute Lymphocytic Leukemia
  • Refractory or Relapsed Acute Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Montefiore Medical CenterBronx, New York  10467-2490