Trial record 6 of 1240 for:    "Mayo Clinic" [Exact]

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00445900
First received: March 7, 2007
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Secondary Myelofibrosis
Drug: cyclophosphamide
Drug: prednisone
Drug: thalidomide
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: biopsy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide ("TPC") in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Confirmed response, defined as a complete or partial response in ≥ 1 of 3 response categories (i.e., anemia, thrombocytopenia, or splenomegaly or hepatomegaly) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Constitutional symptom status and bone marrow morphology [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Toxicity as measured by NCI CTC v 2.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: October 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the benefit of thalidomide, prednisone, and cyclophosphamide in alleviating disease-associated anemia, thrombocytopenia, and/or splenomegaly in patients with myelofibrosis with myeloid metaplasia (MMM).
  • Determine the benefit of this regimen in palliating four hypercatabolic constitutional symptoms (i.e., weight loss, fatigue, drenching night sweats, and unexplained fevers) in these patients.
  • Determine the toxicity profile of this regimen in these patients.

Secondary

  • Determine the effect of this regimen on leukocyte count.
  • Determine the effect of this regimen on bone marrow histology, including microvessel density and reticulin fibrosis.
  • Determine the effect of this regimen on intramedullary and urinary markers of angiogenesis.
  • Determine the effect of this regimen on circulating myeloid progenitor cells by quantifying CD34+ cells.

OUTLINE: Patients receive oral thalidomide, oral prednisone, and oral cyclophosphamide (TPC) once daily on days 1-28. Treatment repeats every 28 days for 3 courses. After 3 courses (3 months) of treatment, patients who respond to TPC therapy may receive oral thalidomide alone once daily for up to 3 months in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspirate and biopsy prior to study entry, 6 months after starting therapy, and then every 6 months for up to 3 years. Samples are analyzed by microvessel density/angiogenesis studies (i.e., CD34 immunohistochemical and vascular endothelium-specific staining) to determine the effect of therapy on markers of bone marrow angiogenesis.

After completion of study therapy, patients are followed every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 22 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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445900

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Ruben A. Mesa, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Ruben A. Mesa, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00445900     History of Changes
Other Study ID Numbers: CDR0000530973, P30CA015083, MC028A, 1360-03
Study First Received: March 7, 2007
Last Updated: March 16, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
primary myelofibrosis
essential thrombocythemia
polycythemia vera
secondary myelofibrosis

Additional relevant MeSH terms:
Primary Myelofibrosis
Metaplasia
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Cyclophosphamide
Thalidomide
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on July 22, 2014