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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Bayer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GM-CSF, Sargramostim Cohort 1 | Experimental | 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 Cohort 2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM-CSF, sargramostim | Drug | GM-CSF subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 460 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Anti-Trag Antibodies | Up to 60 months |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Penson, M.D. | Massachusetts General Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19922985 | Result | 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. |
| Label | URL |
|---|---|
| Sponsor information | View source |
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Phase II
Granulocyte macrophage colony-stimulating factor (GM-CSF) Phase II recruitment from oncology clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | GM-CSF, Sargramostim Cohort 1 | 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. |
| FG001 | GM-CSF, Sargramostim Cohort 2 | GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a 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 the white blood cell count. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
72 ovarian cancer patients with evaluable or measurable disease.
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| ID | Title | Description |
|---|---|---|
| BG000 | GM-CSF, Sargramostim | All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study. In Cohort 1 participants received 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. In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual white cell count (WCC) was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis. | Posted | Median | Full Range | days | Up to 460 days |
|
Between December 2004 and October 2008, 72 eligible and evaluable patients were enrolled. Adverse events (AEs) were collected for 30 calendar days after administration of the last dose of trial drug (Up to 234 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GM-CSF, Sargramostim Cohort 1 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodysplastic syndrome | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard T Penson MD MCCP | MGH DF/HCC | 617-726-8566 | rpenson@partners.org |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C081222 | sargramostim |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Up to 60 months |
| 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. | Up to 60 months |
| 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. | Up to 460 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study. In Cohort 1 participants received 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. In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a 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. |
|
|
| Secondary | 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. | No analysis was performed. No data was reported for TTP in the clinical chart that was found to be reliable or consistent in the absence of proper computed tomography (CT) surveillance. | Posted | Up to 60 months |
|
|
| Secondary | 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. | After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis. | Posted | Count of Participants | Participants | Up to 60 months |
|
|
|
| Secondary | 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. | After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis. | Posted | Count of Participants | Participants | Up to 460 days |
|
|
|
| Other Pre-specified | Change From Baseline of Anti-Trag Antibodies | This outcome measure was originally posted as a secondary outcome measures but was actually an exploratory endpoint. No data was collected. | Posted | Up to 60 months |
|
|
| 2 |
| 35 |
| 35 |
| 35 |
| EG001 | GM-CSF, Sargramostim Cohort 2 | GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count. | 5 | 37 | 37 | 37 |
| Diverticulitis | Infections and infestations | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Difficulty breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever without neutropenia | General disorders | Systematic Assessment |
|
| Rigors/Chills | General disorders | Systematic Assessment |
|
| Weight loss | Investigations | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Induration/fibrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Injection site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hot flashes | Endocrine disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea without prior colostomy | Gastrointestinal disorders | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | Systematic Assessment |
|
| Hyperglycemia | Investigations | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Abdomen pain | Gastrointestinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chest wall pain | General disorders | Systematic Assessment |
|
| Extremity limb pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal cavity/paranasal sinus reaction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary/upper respiratory other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hematologic-other | Blood and lymphatic system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Distention/bloating abdominal | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal other | Gastrointestinal disorders | Systematic Assessment |
|
| Sinus Infection | Infections and infestations | Systematic Assessment |
|
| Edema limb | Metabolism and nutrition disorders | Systematic Assessment |
|
| Neuropathy sensory | Nervous system disorders | Systematic Assessment |
|
| Ocular other | Eye disorders | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Pain other | General disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Incontinence urinary | Renal and urinary disorders | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | Systematic Assessment |
|
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Title | Measurements |
|---|---|
|
| Abnormal liver function test |
|
| Vomiting |
|
| Metabolic |
|
| Small bowel obstruction |
|
| Myelodysplasia |
|
| Urticaria |
|
| Abdominal pain |
|
| Palpitations |
|
| Hypertension |
|
| Changes in bowel habit |
|
| Diverticulitis |
|
| Gout |
|
| Headache |
|
| Macular tuft |
|
| Nausea sinus |
|
| Bradycardia |
|