Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT00006092

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

30.9

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: Arsenic Trioxide	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2000

Actual Primary Completion Date :

Mar 1, 2003

Actual Study Completion Date :

Mar 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arsenic Trioxide Treatment 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.	Drug: Arsenic Trioxide Other Names: Trisenox

Arm

Intervention/Treatment

Experimental: Arsenic Trioxide Treatment

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.

Drug: Arsenic Trioxide

Other Names:

Trisenox

Outcome Measures

Primary Outcome Measures

Objective Rate of Response (ORR) [2.5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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