Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00016159

Purpose

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.

Condition	Intervention	Phase
Leukemia	Biological: filgrastim Biological: lintuzumab Drug: arsenic trioxide Drug: idarubicin Drug: tretinoin	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: acute promyelocytic leukemia

MedlinePlus related topics: Acute Myeloid Leukemia Arsenic Cancer Leukemia

Drug Information available for: Idarubicin hydrochloride Idarubicin Filgrastim Lenograstim Granulocyte colony-stimulating factor Lintuzumab Tretinoin Arsenic trioxide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

reverse transcriptase-polymerase chain reaction negativity [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	November 2000
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016159

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Joseph G. Jurcic, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00016159 History of Changes
Other Study ID Numbers:	CDR0000068600, MSKCC-00072, NCI-H01-0073
Study First Received:	May 6, 2001
Last Updated:	December 16, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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)

Additional relevant MeSH terms:

Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Idarubicin
Arsenic trioxide
Tretinoin
Lenograstim

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 13, 2012