Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis

NCT00630994 | Terminated Phase 2 Results DMC

• 5 other identifiers: CDR0000588839P30CA015083MC0788NCI-2009-0133007-005296
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine works in treating patients with symptomatic myelofibrosis.

Conditions

Chronic Myeloproliferative Disorders; Secondary Myelofibrosis

Keywords

primary myelofibrosis; secondary myelofibrosis; essential thrombocythemia; polycythemia vera

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.

  Confirmed response: objective status of CR, PR, or CI on 2 consecutive evaluations \>=4 weeks apart. CR:Complete resolution of disease-related symptoms and signs; peripheral blood count remission; normal leukocyte differential; bone marrow histologic remission. PR: All criteria for CR except the bone marrow histologic remission. CI: one of the following in the absence of both disease progression and CR/PR: minimum (MI) 20-g/L increase (INC) in hemoglobin level; MI 50% reduction in palpable splenomegaly (\>=10cm); MI 100% INC in platelet count(\>=50000x10\^9/L) or ANC (\>=0.5x10\^9/L)

  Every 4 weeks during treatment (up to 16 weeks)

Secondary Outcomes (4)

• Overall Survival(OS)

  up to 3 years

• Time to Disease Progression

  up to 3 years

• Number of Participants With Constitutional Symptoms

  Up to 48 weeks

• Number of Participants With Severe Adverse Events

  Up to 48 weeks

Interventions

Dacogen DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histological confirmation of primary myelofibrosis or post essential thrombocythemic or polycythemic vera myelofibrosis * Reticulin fibrosis ≥ grade 1 * Evaluable and symptomatic disease worthy of treatment, characterized by ≥ 1 of the following: * Anemia, defined as hemoglobin \< 11 g/dL or erythrocyte transfusion dependence * Palpable and symptomatic splenomegaly (palpable and symptomatic hepatomegaly is acceptable if previously splenectomized) * Severe, disease-related constitutional symptoms, including ≥ 1 of the following: * Severe night sweats * Fevers * Weight loss * Bone pain * Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics OR prior demonstration of a lack of this translocation PATIENT CHARACTERISTICS: * Eastern Co-operative Oncology Group (ECOG) performance status 0-3 * Absolute neutrophil count (ANC) ≥ 1,000/mm³ * Platelet count ≥ 50,000/mm³ * Creatinine ≤ 2.0 mg/dL * Direct or total bilirubin ≤ 2.0 mg/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN if elevation is attributed to hepatic extramedullary hematopoiesis) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Not incarcerated in a municipality, county, state, or federal prison * No serious medical condition or psychiatric illness that would preclude signing the informed consent * No condition that, in the opinion of the treating physician, places the patient at unacceptable risk for study participation or confounds the ability to interpret study data * Able to adhere to the study visit schedule and other study requirements PRIOR CONCURRENT THERAPY: * No other concurrent chemotherapy (e.g., hydroxyurea, thalidomide, interferon alpha, anagrelide, or other myelosuppressive agent) or experimental therapy

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

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

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

Interventions

Decitabine

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)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Study terminated early. Most analyses were not performed.

Results Point of Contact

• Title: Dr. Ruben A. Mesa
• Organization: Mayo Clinic

mesa.ruben@mayo.edu

507-284-2511

Study Officials

• Ruben A. Mesa, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 7, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: April 1, 2012
• Last Updated: December 30, 2015
• Results First Posted: April 2, 2012

Record last verified: 2012-11

Locations

US (1)