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Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
lintuzumab
arsenic trioxide
idarubicin
tretinoin
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring adult acute myeloid leukemia in remission, childhood acute myeloid leukemia in remission, adult acute promyelocytic leukemia (M3), childhood acute promyelocytic leukemia (M3), adult acute myeloid leukemia with t(15;17)(q22;q12)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of acute promyelocytic leukemia by positive RT-PCR assay for PML/RAR-alfa rearrangement or a t(15;17) karyotype Achieved clinical complete remission within the past 1-2 months Prior induction therapy must have contained tretinoin No other acute myeloid leukemia diagnosis PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL Transaminases no greater than 3 times upper limit of normal Renal: Creatinine less than 2 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: Ejection fraction normal or greater than 50% by echocardiogram or MUGA Other: No other concurrent active malignancy No other serious or life-threatening condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 4 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 1 week since prior retinoids Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior postremission therapy of any form

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

reverse transcriptase-polymerase chain reaction negativity

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00016159
Brief Title
Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia
Official Title
Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response (Adaptive Regulation) In The Treatment Of Acute Promyelocytic Leukemia (APL)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and monoclonal antibody in treating patients who have acute promyelocytic leukemia.
Detailed Description
OBJECTIVES: Determine the disease-free and overall survival of patients with acute promyelocytic leukemia in clinical complete remission following tretinoin-based induction therapy treated with monoclonal antibody HuG1-M195, arsenic trioxide, idarubicin, and tretinoin. Determine the rate of molecular complete remission in patients treated with this regimen. Determine the toxicity of this regimen in this patient population. Determine the number and length of hospitalizations of patients treated with this regimen. OUTLINE: Patients receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 40-60 minutes twice weekly for 3 weeks. Approximately 2-4 weeks after completion of MOAB HuM195, patients receive arsenic trioxide IV over 1-4 hours daily for a total of 25 days with no more than 5 days between doses. Beginning approximately 4-6 weeks after completion of arsenic trioxide, patients receive idarubicin IV daily on days 1-3 or 1-4 and filgrastim (G-CSF) subcutaneously daily beginning on day 5 or 6 and continuing until blood counts recover. Treatment repeats every 4 weeks for patients who remain RT-PCR positive or are newly converted to RT-PCR negative (molecular complete remission) following a prior course of idarubicin for a maximum of 3 courses. Patients who remain RT-PCR positive following course 3 of idarubicin receive no further treatment on study. Beginning 3 months after completion of idarubicin, patients in molecular complete remission receive oral tretinoin daily for 14 days. Treatment repeats every 3 months for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly. PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 2-3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
adult acute myeloid leukemia in remission, childhood acute myeloid leukemia in remission, adult acute promyelocytic leukemia (M3), childhood acute promyelocytic leukemia (M3), adult acute myeloid leukemia with t(15;17)(q22;q12)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
lintuzumab
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Type
Drug
Intervention Name(s)
tretinoin
Primary Outcome Measure Information:
Title
reverse transcriptase-polymerase chain reaction negativity

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of acute promyelocytic leukemia by positive RT-PCR assay for PML/RAR-alfa rearrangement or a t(15;17) karyotype Achieved clinical complete remission within the past 1-2 months Prior induction therapy must have contained tretinoin No other acute myeloid leukemia diagnosis PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL Transaminases no greater than 3 times upper limit of normal Renal: Creatinine less than 2 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: Ejection fraction normal or greater than 50% by echocardiogram or MUGA Other: No other concurrent active malignancy No other serious or life-threatening condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 4 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 1 week since prior retinoids Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior postremission therapy of any form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph G. Jurcic, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia

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