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

16 mars 2011 uppdaterad av: Mayo Clinic

Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide ("TPC") in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM)

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

Fas

Fas 2

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Maskning: Ingen (Open Label)

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Dags för progression
Progressionsfri överlevnad
Total överlevnad
Varaktighet för svar
Constitutional symptom status and bone marrow morphology
Toxicity as measured by NCI CTC v 2.0

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Mayo Clinic

Samarbetspartners

National Cancer Institute (NCI)

Utredare

Studiestol: Ruben A. Mesa, MD, Mayo Clinic

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2004

Primärt slutförande (Faktisk)

1 oktober 2006

Avslutad studie (Faktisk)

1 oktober 2006

Studieregistreringsdatum

Först inskickad

7 mars 2007

Först inskickad som uppfyllde QC-kriterierna