Lenalidomide and Prednisone in Treating Patients With Myelofibrosis
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders |
Drug: lenalidomide Drug: prednisone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia |
- Overall response monthly [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
| Estimated Enrollment: | 41 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the rate of complete or partial remission in patients with myelofibrosis with myeloid metaplasia treated with lenalidomide and prednisone.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
- Determine the effect of this regimen on bone marrow fibrosis, angiogenesis, and cytogenetics in these patients.
OUTLINE: This is a multicenter study.
For courses 1 and 2, patients receive oral lenalidomide once daily and oral prednisone once daily on days 1-28. For course 3, patients receive oral lenalidomide once daily on days 1-28 and oral prednisone once on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Patients with stable or responding disease after course 3 receive oral lenalidomide alone once daily on days 1-28 for courses 4-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 5 years from study entry.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study within 11 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of myelofibrosis with myeloid metaplasia, including any of the following subtypes:
- Agnogenic myeloid metaplasia
- Post-polycythemic myeloid metaplasia
- Post-thrombocythemic myeloid metaplasia
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≤ 10 g/dL OR
- Transfusion dependent
Hepatic
- Total or direct bilirubin ≤ 2.0 mg/dL
- AST ≤ 3 times upper limit of normal (unless due to hepatic extramedullary hematopoiesis)
- No hepatitis A, B, or C infection
Renal
- Creatinine ≤ 2.0 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No condition or laboratory abnormality that would preclude study participation
- No other active malignancy
- No known hypersensitivity to thalidomide or lenalidomide
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior lenalidomide
- At least 28 days since prior interferon alfa, thalidomide, or growth factors
- No concurrent growth factors
Chemotherapy
- At least 28 days since prior chemotherapy
- At least 28 days since prior hydroxyurea
Endocrine therapy
- At least 28 days since prior systemic corticosteroids
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Recovered from prior therapy
- At least 28 days since prior anagrelide or other myelosuppressive agents
- At least 28 days since prior experimental therapy
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, California | |
| California Cancer Care, Incorporated - Greenbrae | |
| Greenbrae, California, United States, 94904 | |
| United States, Colorado | |
| Aurora Presbyterian Hospital | |
| Aurora, Colorado, United States, 80012 | |
| Boulder Community Hospital | |
| Boulder, Colorado, United States, 80301-9019 | |
| Penrose Cancer Center at Penrose Hospital | |
| Colorado Springs, Colorado, United States, 80933 | |
| CCOP - Colorado Cancer Research Program | |
| Denver, Colorado, United States, 80224-2522 | |
| Rose Medical Center | |
| Denver, Colorado, United States, 80220 | |
| St. Joseph Hospital | |
| Denver, Colorado, United States, 80218 | |
| Porter Adventist Hospital | |
| Denver, Colorado, United States, 80210 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80110 | |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | |
| Grand Junction, Colorado, United States, 81502 | |
| Sky Ridge Medical Center | |
| Lone Tree, Colorado, United States, 80124 | |
| Hope Cancer Care Center at Longmont United Hospital | |
| Longmont, Colorado, United States, 80502 | |
| St. Mary - Corwin Regional Medical Center | |
| Pueblo, Colorado, United States, 81004 | |
| North Suburban Medical Center | |
| Thornton, Colorado, United States, 80229 | |
| Exempla Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Altanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Alexian Brothers Radiation Oncology | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Evanston Northwestern Healthcare - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Clinic, PC | |
| Galesburg, Illinois, United States, 61401 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| Swedish-American Regional Cancer Center | |
| Rockford, Illinois, United States, 61104-2315 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| Regional Cancer Center at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781-0001 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| William N. Wishard Memorial 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 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, Kansas | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Michigan | |
| Saint Joseph Mercy Cancer Center | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Foote Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48912-1811 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Jersey | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | |
| Marlton, New Jersey, United States, 08053 | |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| 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 | |
| Geisinger Medical Group - Scenery Park | |
| State College, Pennsylvania, United States, 16801 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Wisconsin | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Marshfield Clinic - Indianhead Center | |
| Rice Lake, Wisconsin, United States, 54868 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel | |
| Study Chair: | Ayalew Tefferi, MD | Mayo Clinic |
| Investigator: | Larry D. Cripe, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
Additional Information:
No publications provided by Eastern Cooperative Oncology Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00227591 History of Changes |
| Other Study ID Numbers: | CDR0000442403, U10CA021115, ECOG-E4903 |
| Study First Received: | September 26, 2005 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eastern Cooperative Oncology Group:
|
chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Prednisone Lenalidomide Thalidomide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal |
Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013