Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003910

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 methotrexate with or without cyclophosphamide in treating patients who have lymphocytic leukemia with neutropenia or anemia.

Condition	Intervention	Phase
Leukemia	Drug: cyclophosphamide Drug: methotrexate Drug: prednisone	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic (LGL) Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cyclophosphamide Prednisone Methotrexate

U.S. FDA Resources

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

Primary Outcome Measures:

Complete, partial, and overall response rates [ Designated as safety issue: No ]
Clinical response [ Designated as safety issue: No ]
Toxic effects [ Designated as safety issue: Yes ]

Estimated Enrollment:	88
Study Start Date:	July 1999
Estimated Primary Completion Date:	May 2001 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the complete, partial, and overall response rates to methotrexate in patients with large granular lymphocytic (LGL) leukemia presenting with neutropenia or anemia.
Determine the complete, partial, and overall response rates to cyclophosphamide in the patients who fail to respond to methotrexate.
Assess the association of clinical response with increased sensitivity of leukemic LGL to Fas-dependent apoptosis, reduction in levels of Fas ligand, and disappearance of leukemic clone.
Determine the toxic effects of methotrexate and cyclophosphamide in these patients.

OUTLINE: Patients are stratified according to symptom (neutropenia vs anemia).

Patients receive oral methotrexate once a week for 4 months and oral prednisone daily for 54 days. Patients who show a partial response to methotrexate may continue this therapy for up to 1 year. Patients who do not respond to this therapy after 4 months then receive oral cyclophosphamide daily for up to 1 year and oral prednisone daily for 54 days.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 38-88 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Cytologically proven T-cell large granular lymphocytic (LGL) leukemia
- Absolute LGL count greater than 500/mm3 (peripheral blood only)
- CD3+ and CD57+ cells greater than 400/mm3 OR
- CD8+ cells greater than 650/mm3
- Clonal T-cell receptor gene rearrangement
- At least 1 of the following:
  - Severe neutropenia (neutrophil count less than 500/mm3)
  - Neutropenia associated with recurrent infections
  - Symptomatic anemia
  - Transfusion dependent anemia

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 2 years

Hematopoietic:

See Disease Characteristics

Hepatic:

Bilirubin no greater than 2.0 mg/dL
SGOT no greater than 1.5 times normal

Renal:

Creatinine no greater than 2.0 mg/dL

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior or concurrent malignancy within past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
No other serious medical illness
No concurrent psychiatric condition

PRIOR CONCURRENT THERAPY:

No prior oral methotrexate or cyclophosphamide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003910

Hide Study Locations

Locations

United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
North Colorado Medical Center
Greeley, Colorado, United States, 80631
North Suburban Medical Center
Thornton, Colorado, United States, 80229
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
St. Joseph Hospital
Denver, Colorado, United States, 80218
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Swedish Medical Center
Englewood, Colorado, United States, 80110
United States, Georgia
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
United States, Illinois
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
United States, Indiana
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46202
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
United Hospital
Saint Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Ohio
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
St. Rita's Medical Center
Lima, Ohio, United States, 45801
United States, Pennsylvania
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lemoyne, Pennsylvania, United States, 17043
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Wisconsin
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Thomas P. Loughran, MD

Milton S. Hershey Medical 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

Responsible Party:	ECOG Group Chair's Office ( Robert L. Comis )
Study ID Numbers:	CDR0000067089, ECOG-5998
Study First Received:	November 1, 1999
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00003910 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
T-cell large granular lymphocyte leukemia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Prednisone
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Reproductive Control Agents
Hormones
Leukemia
Therapeutic Uses

Abortifacient Agents
Methotrexate
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009