GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: GM-CSF, sargramostim
Intervention description: GM-CSF subcutaneous injection
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asymptomatic; Clinical trial; Phase II; GM-CSF; Immunotherapy

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.
    

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.