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Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia

This study has been withdrawn prior to enrollment.
(No enrollment.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00006090
First received: August 3, 2000
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 chronic lymphocytic leukemia that has relapsed or has not responded to treatment with fludarabine.


Condition Intervention Phase
Leukemia
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Arsenic Trioxide (NSC #706363) Therapy for Fludarabine Refractory or Relapsed Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 0
Study Start Date: June 2000
Study Completion Date: October 2001
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the clinical efficacy and safety of arsenic trioxide in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine or in relapse. II. Determine the pattern of clinical adverse experience in these patients when treated with this regimen. III. Evaluate the effects of this drug on cytokines, apoptosis, and angiogenesis in these patients.

OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-15 OR on days 1-5, 8-12, and 15-19. Courses repeat with 2 to 5 week intervals between courses for 10-12 courses (about 1 year) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for the second year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Relapsed or refractory chronic lymphocytic leukemia (CLL) Previously treated with alkylating agent Refractory or intolerant to fludarabine as defined by: Progressive disease during treatment with fludarabine Stable disease (no partial or complete response) after at least 2 courses of fludarabine Relapse or progressive disease within 6 months of treatment with fludarabine Autoimmune hemolytic anemia or idiopathic thrombocytopenia concurrent with or within 1 month after completion of fludarabine Grade 2 pulmonary toxicity or neurotoxicity that would preclude further treatment with fludarabine OR Progressive B-cell CLL as defined by at least 1 of the following: Hemoglobin less than 11 g/dL, or progressive decline Platelet count no greater than 100,000/mm3, or progressive decline Massive (greater than 6 cm below costal margin) or progressive splenomegaly Massive lymph nodes or clusters or progressive lymphadenopathy At least 10% weight loss in past 6 months Fatigue grade 2-3 Fever (greater than 100.5 F) or night sweats for greater than 2 weeks without evidence of infection Progressive lymphocytosis greater than 50% over 2 month period, or anticipated doubling time less than 6 months Lymphocyte count greater than 100,000/mm3 No uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia No other uncontrolled immune phenomena related to CLL No CNS metastases

PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Zubrod 0-2 Life expectancy: At least 2 years Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease or direct CLL infiltration of liver) SGOT or SGPT no greater than 2.5 times ULN (unless due to direct CLL infiltration of liver) No hepatic disease that would preclude study Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No unstable angina pectoris No cardiac arrhythmia No prior grade III or IV New York Heart Association cardiac problem No cardiovascular disease that would preclude study Other: No prior grand mal seizures (infantile febrile seizures allowed) No other active malignancy No other uncontrolled concurrent medical problem No active uncontrolled infection No prior hypersensitivity to arsenic trioxide or related drugs No neurologic, endocrine, or other systemic disease that would preclude study No other condition that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent stem cell transplant Chemotherapy: See Disease Characteristics At least 14 days since prior chemotherapy and recovered (unless evidence of disease progression) No concurrent chemotherapy No prior arsenic treatment Endocrine therapy: No concurrent steroidal or hormonal therapy for cancer Steroids for adrenal failures and hormones for nondisease conditions allowed Radiotherapy: At least 14 days since prior radiotherapy and recovered (unless evidence of disease progression) No concurrent radiotherapy Other: At least 14 days since other investigational agents and recovered (unless evidence of disease progression) No concurrent other investigational agents

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006090

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Deborah A. Thomas, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00006090     History of Changes
Other Study ID Numbers: CDR0000068092, MDA-DM-00059, NCI-310, ID00-059
Study First Received: August 3, 2000
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Arsenic trioxide
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014