Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

Leukemia Clinical Trial

Official title:

A Phase II Study of Arsenic Trioxide for Induction Therapy of Adult Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and Previously Untreated Chronic Myeloid Leukemia With Blast Crisis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006092
• Other study ID #: MCC-12395
• Secondary ID: NCI-1230
• Status: Terminated
• Phase: Phase 2
• First received: August 3, 2000
• Last updated: September 25, 2012
• Start date: August 2000
• Est. completion date: March 2003

Study information

• Verified date: September 2012
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.

Description:

OBJECTIVES:

• Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.

• Determine the duration of hematologic response and overall survival of these patients when treated with this regimen.

• Determine the pattern of clinical adverse experience in these patients when treated with this regimen.

• Determine the pharmacokinetic profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.

Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of one of the following:

• Acute lymphoblastic leukemia

• Philadelphia chromosome (Bcr-abl) positive

• Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation

• Blastic phase chronic myelogenous leukemia

• Philadelphia chromosome (Bcr-abl) positive

• Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate

• Must not be eligible for bone marrow transplant

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.0 times upper limit of normal (ULN)

• AST/ALT no greater than 2 times ULN

Renal:

• Creatinine no greater than 2.0 times ULN

• Creatinine clearance greater than 70 mL/min

Cardiovascular:

• No uncontrolled angina

• No New York Heart Association class III or IV heart disease

• No second degree heart block without pacemaker

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study

• HIV negative

• No uncontrolled infection or other serious concurrent illness

• No peripheral neuropathy

• No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR

• No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected

• Electrolyte imbalances must be corrected prior to study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

• At least 28 days since prior chemotherapy

• At least 24 hours since prior hydroxyurea

• No prior arsenic trioxide

• No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 28 days since prior radiotherapy

• No concurrent radiotherapy including for palliation

Surgery:

• Not specified

Other:

• At least 14 days since prior imatinib mesylate

• No other concurrent investigational agents

• No concurrent amphotericin B

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Arsenic Trioxide

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Rate of Response (ORR)	Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.	2.5 years	No