Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Molgramostim

Sargramostim

Immunomodulating Agents

Immunologic Factors

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.

GM-CSF, sargramostim

Richard T Penson, M.D.

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.

GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma

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.

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.

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.

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.

Dana-Farber Cancer Institute

Bayer

Massachusetts General Hospital

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 1

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.

GM-CSF, Sargramostim Cohort 2

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.

GM-CSF, Sargramostim

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

72 ovarian cancer patients with evaluable or measurable disease.

Richard T Penson MD MCCP

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.

Median Time to Treatment Termination (TTT)

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.

Median Time to Progression (TTP)

Complete Response

Partial Response

Stable Disease

Progressive Disease

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.

Tumor Response Rate (RR)

Thrombocytopenia

Musculoskeletal pain

Fatigue

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

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.

Number of Participants With Adverse Events (Toxicity) Grade 3 or 4

This outcome measure was originally posted as a secondary outcome measures but was actually an exploratory endpoint. No data was collected.

Change From Baseline of Anti-Trag Antibodies

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.

Overall Study

Spots Global Cancer Trial Database for GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial