GM-CSF in Women With Recurrent Ovary Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157573
• Other study ID #: 04-305
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: April 27, 2012
• Start date: December 2004
• Est. completion date: April 2010

Study information

• Verified date: April 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Intervention

Drug:
• GM-CSF, Leukine
GM-CSF 150 mcg given subcutaneously daily without interruption

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Bayer, Dana-Farber Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the time to treatment termination due to disease progression or toxicity		every 3 months	No
Secondary	To determine the toxicity of this therapy		every 2 weeks	Yes
Secondary	To determine the development of anti-Trag antibodies		every 2 months	No

External Links

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