Clinical trial NCT00157573: GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer
Official title: Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Keywords: Asymptomatic
Clinical trial
Phase II
GM-CSF
Immunotherapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Bayer
First posted: 2005-09-12
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Granulocyte macrophage colony-stimulating factor (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.

Detailed description: This is an open labeled, single arm phase II study of GM-CSF, sargramostim 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 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 cancer antigen 125 (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 computed tomography (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.
* Eastern Cooperative Oncology Group (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 Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy (except alopecia).
* Serum creatinine level greater than CTC grade 2 \[1.5 x upper limit normal (ULN)\].
* 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.

Primary outcomes:
measure: Median Time to Treatment Termination (TTT)
timeFrame: Up to 460 days
Secondary outcomes:
measure: Median Time to Progression (TTP)
timeFrame: Up to 60 months
measure: Tumor Response Rate (RR)
timeFrame: Up to 60 months
measure: Number of Participants With Adverse Events (Toxicity) Grade 3 or 4
timeFrame: Up to 460 days
Other outcomes:
measure: Change From Baseline of Anti-Trag Antibodies
timeFrame: Up to 60 months
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Richard T Penson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roche MR, Rudd PJ, Krasner CN, Matulonis UA, Berlin ST, Lee H, Silver M, Tran CD, Seiden MV, Penson RT. Phase II trial of GM-CSF in women with asymptomatic recurrent mullerian tumors. Gynecol Oncol. 2010 Feb;116(2):168-72. doi: 10.1016/j.ygyno.2009.10.075. Epub 2009 Nov 18.