Recruiting
Phase 1
Phase 2

Liposomal Annamycin

Sponsor:

Callisto Pharmaceuticals

Code:

NCT00271063

Conditions

Acute Lymphocytic Leukemia

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Liposomal Annamycin

Study Details

Brief summary:

This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.

Conditions

Acute Lymphocytic Leukemia

Study ID

NCT00271063

Start date

Oct, 2005

Status verified date

Dec, 2007

Completion date

Apr, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Liposomal Annamycin

3-day IV infusion

Primary outcome measure

  • To evaluate the safety and tolerability of L-Annamycin [ Time Frame: 8 months ]
  • MTD [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Craig C. Talluto, PhD, abd

212-297-0010ctalluto@callistopharma.com

Locations

Montefiore Medical Center

Recruiting

Bronx, New York, United States, 10467

Contacts

Dominique Pinard, MS

718-920-2090

Principal Investigator:

Samir Parekh, MD

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Barbara Anderson, RN

716-845-8360

Principal Investigator:

Meir Wetzler, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Michelle Thomas, RN, BSN, OCN

713-763-8776

Principal Investigator:

Hagop Kantarjian, MD

More Information

Sponsor

Callisto Pharmaceuticals

Last update posted

Dec 21, 2007

Last verified

Dec, 2007

Keywords

  • Refractory or Relapsed Acute Lymphocytic Leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Callisto Pharmaceuticals on 2007-12-21.