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GM-CSF in Women With Recurrent Ovary Cancer

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, December 2007

Sponsors and Collaborators: Massachusetts General Hospital
Dana-Farber Cancer Institute
Bayer
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00157573
  Purpose

GM-CSF is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. This study looks at ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian cancer.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Drug: GM-CSF, Leukine
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   Sargramostim    Granulocyte-macrophage colony-stimulating factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the time to treatment termination due to disease progression or toxicity [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the toxicity of this therapy [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
  • To determine the development of anti-Trag antibodies [ Time Frame: every 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   70
Study Start Date:   December 2004
Estimated Study Completion Date:   February 2008
Estimated Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: GM-CSF, Leukine
    GM-CSF 150 mcg given subcutaneously daily without interruption
Detailed Description:

This is an open labeled, single arm phase II study of GM-CSF delivered daily without a break in a population of healthy and fit women with evidence of recurrent but asymptomatic mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). The main goal is to determine the time to treatment termination due to disease progression or toxicity.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Patients must have a history of histologic or cytologic diagnosis of primary ovarian, primary peritoneal or tubal carcinoma.

Patients must be asymptomatic from their cancer.

Patients must have evidence of recurrent carcinoma, as determined by:

  • A rising CA-125 serum level greater than 35 U/mL or two successive rising values with the most recent value at least 3 times the nadir value.
  • Or evidence of evaluable or measurable disease by x-ray or CT scan. Patients may not receive concurrent antineoplastic therapy. All hormonal therapy used as a treatment modality (i.e. tamoxifen, arimidex, etc) must be stopped prior to treatment on protocol.

Age > 18 years. ECOG performance status< 2

Exclusion Criteria:

Known severe hypersensitivity to GM-CSF Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or concurrent superficial or stage IB endometrial carcinoma Concomitant use of anti-neoplastic therapy Treatment with a non-FDA approved or investigational drug within 30 days before Day 1 of trial treatment Any unresolved chronic toxicity greater then CTC grade 2 from previous anticancer therapy (except alopecia) Serum creatinine level greater than CTC grade 2 (£ 1.5 x ULN) Pregnancy or breast feeding (women of childbearing potential) Severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as judged by the investigator.

Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate in the trial as judged by the investigator.

Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment.

Patients with clinical and/or radiographic evidence of current or impending bowel obstruction.

Performance status < 1 Ability to understand and the willingness to sign a written informed consent document.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157573

Contacts
Contact: Maria Roche, M.S.N.     617-724-4800     mroche@partners.org    
Contact: Richard T. Penson, M.D.     617-726-1941     rpenson@partners.org    

Locations
United States, Massachusetts
Massachusetts General Hospital     Recruiting
      Boston, Massachusetts, United States, 02114
      Contact: Richard T Penson, M.D.     617-726-1941     rpenson@partners.org    
      Contact: Lisa Smith     617-724-4102     lsmith20@partners.org    
      Principal Investigator: Richard T Penson, M.D.            

Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Bayer

Investigators
Principal Investigator:     Richard T Penson, M.D.     Massachusetts General Hospital    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Massachusetts General Hospital ( Richard T. Penson, MD )
Study ID Numbers:   04-305
First Received:   September 8, 2005
Last Updated:   December 28, 2007
ClinicalTrials.gov Identifier:   NCT00157573
Health Authority:   United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Asymptomatic  
Clinical trial  
Phase II  
GM-CSF  
Immunotherapy  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Fallopian Tube Neoplasms
Recurrence
Carcinoma
Fallopian Tube Diseases
Genital Diseases, Female
Endocrinopathy
Fallopian tube cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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