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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Rate of Response (ORR)

Outcome Description:

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.

Outcome Time Frame:

2.5 years

Safety Issue:

No

Principal Investigator

Thomas P. Loughran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-12395

NCT ID:

NCT00006092

Start Date:

August 2000

Completion Date:

March 2003

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • lymphoid leukemia
  • myeloid and monocytic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612