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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Bayer |
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00157573 |
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 |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
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.
Contact: Maria Roche, M.S.N. | 617-724-4800 | mroche@partners.org |
Contact: Richard T. Penson, M.D. | 617-726-1941 | rpenson@partners.org |
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. |
Massachusetts General Hospital |
Dana-Farber Cancer Institute |
Bayer |
Principal Investigator: | Richard T Penson, M.D. | Massachusetts General Hospital |
Related Info 
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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 |
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