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

Show 68 Study Locations

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 27, 2009