Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 201 for:    "Leukemia" | "Sargramostim"

Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00363649
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.

PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine therapy in treating patients with chronic phase chronic myelogenous leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Biological: GM-K562 cell vaccine Biological: Interferon alfa Biological: Sargramostim Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants were randomly assigned to Arm A or Arm B and received up to twelve months of protocol therapy. If at any point a participant progressed, relapsed, or had unacceptable toxicity, they could cross over to the other arm. Participants could only cross over once.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Interferon + GM-CSF Versus K562/GM-CSF Vaccination in CML Patients Achieving a Complete Cytogenetic Response to Frontline Tyrosine Kinase Inhibitor Therapy
Actual Study Start Date : September 2006
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: Arm A
Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Biological: Interferon alfa
Given by injection

Biological: Sargramostim
Given by injection
Other Name: GM-CSF

Experimental: Arm B
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
Biological: GM-K562 cell vaccine
Given by injection




Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 1 year after treatment has been stopped ]
    Number of patients alive and without disease progression or relapse

  2. Complete Remission Rate [ Time Frame: Up to 18 months ]
    Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity.


Secondary Outcome Measures :
  1. Time to Complete Molecular Remission [ Time Frame: Up to 27 months ]
    Number of months from randomization to molecular remission as defined by polymerase chain reaction negativity.

  2. Disease-free Survival [ Time Frame: Up to 8 years ]
    Median number of days to progression of disease in participants who stopped all treatment as directed by the protocol.

  3. Early Discontinuation [ Time Frame: 1 year ]
    Number of participants unable to complete protocol-specified treatment due to toxicity.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic myelogenous leukemia (CML) in chronic phase based on cytogenetic detection of the Philadelphia chromosome and/or detection of the BCR-ABL rearrangement by any of the following molecular methods:

    • Recombinant DNA analysis of the BCR-ABL fusion gene
    • Fluorescence in situ hybridization (FISH)
    • Polymerase chain reaction detection of the BCR-ABL hybrid mRNA
  • Documentation of complete cytogenetic response by conventional cytogenetic or FISH analysis while on a stable dose of tyrosine kinase inhibitor
  • No other phase of CML

PATIENT CHARACTERISTICS:

  • ECG performance status 0-2
  • Life expectancy > 24 months
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • No other malignancy within the past 5 years except in situ cervical carcinoma or adequately treated nonmelanoma skin cancer
  • No other disease requiring long-term corticosteroids or immunosuppressants

PRIOR CONCURRENT THERAPY:

  • At least 28 days since prior investigational agents
  • No prior bone marrow transplant or other transplant
  • No concurrent immunosuppressants (e.g., steroids, cyclosporine, azathioprine, mycophenolate mofetil, sirolimus, or tacrolimus)
  • No concurrent hydroxyurea, busulfan, or cytoreductive agents (other than frontline TKI)
  • No other concurrent anticancer agents or therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363649


Locations
Layout table for location information
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: B. Douglas Smith, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Study Documents (Full-Text)

Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:

Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00363649     History of Changes
Other Study ID Numbers: J05121
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2006    Key Record Dates
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Philadelphia chromosome positive chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Sargramostim
Neoplasms by Histologic Type
Neoplasms
Interferons
Interferon-alpha
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents