Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
Recruitment status was Active, not recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic (LGL) Leukemia |
- 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) |
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 |
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
Show 68 Study Locations| Study Chair: | Thomas P. Loughran, MD | Milton S. Hershey Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00003910 History of Changes |
| Other Study ID Numbers: | CDR0000067089, ECOG-5998 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 14, 2009 |
| 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:
|
Leukemia Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Methotrexate Prednisone Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013