Back to resultsGM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer
Primary Purpose
Ovarian Cancer, Fallopian Tube Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GM-CSF, sargramostim
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Asymptomatic, Clinical trial, Phase II, GM-CSF, Immunotherapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GM-CSF, Sargramostim Cohort 1
GM-CSF, Sargramostim Cohort 2
Arm 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.
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.
Outcomes
Primary Outcome Measures
Median Time to Treatment Termination (TTT)
TTT is the median time in days to discontinuing treatment with GM-CSF, sargramostim (treatment termination) e.g. time on study until progression of disease, unacceptable adverse effects, bowel obstruction, development of new ascites or pleural effusions, initiation of systemic chemotherapy, participant death, development of co-morbid diseases which make participant continuation on the trial unsafe in the judgment of the principal investigator or the treating physician or withdrawal of consent by the participant.
Secondary Outcome Measures
Median Time to Progression (TTP)
TTP was defined as the median time in days from trial entry until progressive disease (PD) was documented as defined by RECIST criteria. PD was defined of at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In participants with no measurable disease who had an informative cancer antigen-125 (CA-125), PD was defined as a rise of > 50% over Baseline, confirmed by a subsequently higher value at least 21 days later.
Tumor Response Rate (RR)
RR is the percentage of patients with response as assessed by the investigator using Response Evaluable Criteria in Solid Tumors (RECIST) and CA-125 Rustin criteria. Complete Response (CR) is the disappearance of all target and non-target lesions and normalization of CA-125. Partial Response (PR) is at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; in patients with no measurable disease with an informative CA-125, the 75% definitions by Rustin is used. Stable Disease is neither sufficient shrinkage for PR nor increase for PD, taking as reference the smallest sum LD since the treatment start. PD is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start or the appearance of one or more new lesions; in patients with no measurable disease with an informative CA-125, PD is defined as a rise of > 50% over baseline, confirmed by a higher value 21 days later.
Number of Participants With Adverse Events (Toxicity) Grade 3 or 4
Adverse Events (previously toxicity) were graded according the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The total number of participants with adverse events graded 3 (severe) or 4 (life-threatening or disabling) are reported.
Full Information
NCT ID
NCT00157573
First Posted
September 8, 2005
Last Updated
March 27, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00157573
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer
Keywords
Asymptomatic, Clinical trial, Phase II, GM-CSF, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GM-CSF, Sargramostim Cohort 1
Arm Type
Experimental
Arm 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.
Arm Title
GM-CSF, Sargramostim Cohort 2
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
GM-CSF, sargramostim
Other Intervention Name(s)
Leukine®
Intervention Description
GM-CSF subcutaneous injection
Primary Outcome Measure Information:
Title
Median Time to Treatment Termination (TTT)
Description
TTT is the median time in days to discontinuing treatment with GM-CSF, sargramostim (treatment termination) e.g. time on study until progression of disease, unacceptable adverse effects, bowel obstruction, development of new ascites or pleural effusions, initiation of systemic chemotherapy, participant death, development of co-morbid diseases which make participant continuation on the trial unsafe in the judgment of the principal investigator or the treating physician or withdrawal of consent by the participant.
Time Frame
Up to 460 days
Secondary Outcome Measure Information:
Title
Median Time to Progression (TTP)
Description
TTP was defined as the median time in days from trial entry until progressive disease (PD) was documented as defined by RECIST criteria. PD was defined of at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In participants with no measurable disease who had an informative cancer antigen-125 (CA-125), PD was defined as a rise of > 50% over Baseline, confirmed by a subsequently higher value at least 21 days later.
Time Frame
Up to 60 months
Title
Tumor Response Rate (RR)
Description
RR is the percentage of patients with response as assessed by the investigator using Response Evaluable Criteria in Solid Tumors (RECIST) and CA-125 Rustin criteria. Complete Response (CR) is the disappearance of all target and non-target lesions and normalization of CA-125. Partial Response (PR) is at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; in patients with no measurable disease with an informative CA-125, the 75% definitions by Rustin is used. Stable Disease is neither sufficient shrinkage for PR nor increase for PD, taking as reference the smallest sum LD since the treatment start. PD is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start or the appearance of one or more new lesions; in patients with no measurable disease with an informative CA-125, PD is defined as a rise of > 50% over baseline, confirmed by a higher value 21 days later.
Time Frame
Up to 60 months
Title
Number of Participants With Adverse Events (Toxicity) Grade 3 or 4
Description
Adverse Events (previously toxicity) were graded according the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The total number of participants with adverse events graded 3 (severe) or 4 (life-threatening or disabling) are reported.
Time Frame
Up to 460 days
Other Pre-specified Outcome Measures:
Title
Change From Baseline of Anti-Trag Antibodies
Time Frame
Up to 60 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard T Penson, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19922985
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.
Results Reference
result
Links:
URL
http://www.dfhcc.org
Description
Sponsor information
Learn more about this trial
GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer
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