Thalidomide, Prednisone, and Cyclophosphamide in Treating Patients With Myelofibrosis and Myeloid Metaplasia

NCT00445900 | Completed Phase 2

• 4 other identifiers: CDR0000530973P30CA015083MC028A1360-03
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen symptoms caused by myelofibrosis and myeloid metaplasia. PURPOSE: This phase II trial is studying the side effects and how well giving thalidomide together with prednisone and cyclophosphamide works in treating patients with myelofibrosis and myeloid metaplasia.

Conditions

Chronic Myeloproliferative Disorders; Secondary Myelofibrosis

Keywords

primary myelofibrosis; essential thrombocythemia; polycythemia vera; secondary myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Confirmed response, defined as a complete or partial response in ≥ 1 of 3 response categories (i.e., anemia, thrombocytopenia, or splenomegaly or hepatomegaly)

Secondary Outcomes (6)

• Constitutional symptom status and bone marrow morphology

• Overall survival

• Progression-free survival

• Time to progression

• Duration of response

Interventions

cyclophosphamide DRUG

prednisone DRUG

thalidomide DRUG

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed myelofibrosis with myeloid metaplasia (MMM) of any of the following subtypes: * Agnogenic myeloid metaplasia * Post-polycythemic myeloid metaplasia * Post-thrombocythemic myeloid metaplasia * Must have 1 of the following MMM-related conditions: * Anemia, defined as hemoglobin \< 10 g/dL * Iron deficiency must be excluded as cause * Thrombocytopenia, defined as platelet count \< 100,000/mm³ * Palpable hepatomegaly or splenomegaly * No evidence of myelofibrosis-associated conditions in the bone marrow, including any of the following: * Metastatic carcinoma * Lymphoma * Myelodysplasia * Hairy cell leukemia * Mast cell disease * Acute leukemia (including M7 type) * Acute myelofibrosis * No chromosomal translocation t(9:22) or bcr-abl as determined by bone marrow chromosome analysis or peripheral blood fluorescent in situ hybridization (FISH) analysis PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Absolute neutrophil count ≥ 750/mm³ * Bilirubin ≤ 2 times upper limit of normal (ULN), unless elevation due to MMM * AST ≤ 5 times ULN, unless elevation due to MMM * Creatinine ≤ 2.5 mg/dL * No uncontrolled infection, including tuberculosis * No known history of positive purified protein derivative (PPD) untreated by isoniazid therapy * Positive PPD with normal chest X-ray and completion of full-course isoniazid therapy allowed * No federal medical center inmates or other incarcerated patients * No peripheral neuropathy ≥ grade 2 * No comorbid condition in which the use of study therapy is felt to be potentially harmful * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception PRIOR CONCURRENT THERAPY: * No chemotherapy (e.g., hydroxyurea, myelosuppressive therapy) within the past 14 days * Prior splenectomy for MMM allowed * No concurrent hematopoietic growth factors

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Myeloproliferative Disorders; Primary Myelofibrosis; Thrombocythemia, Essential; Polycythemia Vera

Interventions

Cyclophosphamide; Prednisone; Thalidomide; Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Ruben A. Mesa, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 9, 2007
• Study Start: October 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: March 17, 2011

Record last verified: 2011-03