Expired Study
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Milwaukee, Wisconsin 53295


Purpose:

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 relapsed or refractory acute lymphoblastic leukemia.


Study summary:

OBJECTIVES: - Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide. - Determine the toxic effects of induction arsenic trioxide in this patient population. OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week). Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.


Criteria:

DISEASE CHARACTERISTICS: - Morphologically proven acute lymphoblastic leukemia (ALL) - Subtypes L1, L2, or L3 - Bone marrow morphology with greater than 25% lymphoblasts - ALL morphology and cytochemistry with myeloid markers eligible - Refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation - Any number of prior relapses allowed - No relapse following allogeneic transplantation - Prior CNS leukemia allowed if treated and currently disease-free PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 6 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT/SGPT no greater than 2 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN Renal: - Creatinine no greater than 2 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant active infection - No other medical conditions that would likely decrease life expectancy - No other prior malignancy within the past 5 years except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine therapy: - At least 2 weeks since prior systemic corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent antibiotics for active or resolving infection


Study is Available At:


Original ID:

CDR0000068016


NCT ID:

NCT00006008


Secondary ID:

E-9998


Study Acronym:


Brief Title:

Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia


Official Title:

A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Mark R. Litzow, MD
Study Chair
Mayo Clinic

Study Dates

Start Date:June 2000
Completion Date:September 2006
Completion Type:Actual
Verification Date:August 2002
Last Changed Date:June 20, 2013
First Received Date:July 5, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:arsenic trioxide

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Eastern Cooperative Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Litzow MR, Lee S, Bennett JM, Dewald GW, Gallagher RE, Jain V, Paietta EM, Racevskis J, Rousey SR, Mazza JJ, Tallman MS. A phase II trial of arsenic trioxide for relapsed and refractory acute lymphoblastic leukemia. Haematologica. 2006 Aug;91(8):1105-8. Epub 2006 Jul 25.
PMID:16870552

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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