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GM-CSF in Women With Recurrent Ovary Cancer

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Bayer
Information provided by (Responsible Party):
Richard Thomas Penson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00157573
First received: September 8, 2005
Last updated: April 27, 2012
Last verified: April 2012
  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 2

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

Resource links provided by NLM:


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
Study Completion Date: April 2010
Primary Completion Date: October 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
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: NCT00157573

Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Bayer
Investigators
Principal Investigator: Richard T Penson, M.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Thomas Penson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00157573     History of Changes
Other Study ID Numbers: 04-305
Study First Received: September 8, 2005
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014