GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: GM-CSF, sargramostim

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00157573

04-305

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

GM-CSF, Sargramostim Cohort 1

Experimental group

Description:

GM-CSF, Sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.

Treatment:

Drug: GM-CSF, sargramostim

GM-CSF, Sargramostim Cohort 2

Experimental group

Description:

GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity fora median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count.

Treatment:

Drug: GM-CSF, sargramostim