CLINICAL TRIAL

GM-CSF for Fallopian Tube Cancer

1 Prior Treatment
Recurrent
Stage III
Waitlist Available · 18+ · Female · Boston, MA

This study is evaluating the effect of a dendritic cell/tumor fusion vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the participants immune system.

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About the trial for Fallopian Tube Cancer

Eligible Conditions
Fallopian Tubes Cancer · Carcinoma, Ovarian Epithelial · Fallopian Tube Neoplasms · Ovarian Neoplasms · Ovarian Cancer · Primary Peritoneal Cancer

Treatment Groups

This trial involves 2 different treatments. GM-CSF is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
GM-CSF
DRUG
+
Dendritic Cell/Tumor Fusion Vaccine
BIOLOGICAL
Experimental Group 2
GM-CSF
DRUG
+
Dendritic Cell/Tumor Fusion Vaccine
BIOLOGICAL
+
imiquimod
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GM-CSF
2014
Completed Phase 4
~1340
Imiquimod
FDA approved

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Fallopian Tube Cancer or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
are candidates for maintenance therapy with bevacizumab Patients with ovarian cancer who don't experience disease progression, as verified by clinical assessment, CA-125 levels, and/or radiographic assessment, may be candidates for maintenance therapy with bevacizumab. show original
Every patient must be aware of the experimental nature of this study and must provide written consent in accordance with institutional and federal guidelines. show original
Before a person can be vaccinated for HPV, they must meet eligibility criteria show original
Nearly all of the patients who received first-line chemotherapy for newly-diagnosed ovarian cancer had a complete clinical response show original
Some people have a low-level, asymptomatic form of the disease that doesn't require any more treatment before they can start getting vaccinated. show original
A complete clinical response is defined as a normal exam, a normal CT scan, and a normal CA-125 level show original
Patients who have ovarian, fallopian tube, or primary peritoneal cancer and have undergone therapeutic debulking surgery are eligible to participate in this study show original
This patient's laboratory results show that their white blood cell count is high, their platelets are high, their bilirubin is low, their creatinine is low, and their AST/ALT are low. show original
within 4 weeks The text is saying that all chemotherapy-related grade III-IV toxicity will be resolved within 4 weeks. show original
Patients must be in good health and have a life expectancy of more than six weeks. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether GM-CSF will improve 1 primary outcome and 3 secondary outcomes in patients with Fallopian Tube Cancer. Measurement will happen over the course of 2 years.

To determine if cellular immunity is induced by serial vaccination with DC/tumor fusion cells, when given with GM-CSF alone, or the combination of GM-CSF and imiquimod in this patient population.
2 YEARS
2 YEARS
To assess toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.
2 YEARS
2 YEARS
To assess clinical response to vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.
2 YEARS
2 YEARS
To correlate immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation.
2 YEARS
2 YEARS

Who is running the study

Principal Investigator
D. A.
David Avigan, MD
Beth Israel Deaconess Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get fallopian tube cancer a year in the United States?

About 9,500 women and one man develop fallopian tube cancer in the United States each year. This is a significant increase over a 22-year period (1973–1995).

Anonymous Patient Answer

What is fallopian tube cancer?

Fallopian tube cancer can present with pelvic masses, abdominal pain, fever, and/or vaginal bleeding. Diagnosis at both primary and secondary care sites is challenging for both clinicians and students. It is a more common cancer than many thought previously.

Anonymous Patient Answer

What are the signs of fallopian tube cancer?

Fallopian tube cancer is often asymptomatic and is thus a disease often diagnosed at a later stage. The use of BRCA1 and BRCA2 sequences as a diagnostic modality for these high-risk cancers are being investigated.

Anonymous Patient Answer

What causes fallopian tube cancer?

While there is no clear cause of fallopian tube cancer, there will be increased awareness of these high risk women and their heightened interest in maintaining good health behaviours. In the future, health care providers might assess for underlying infertility even if there is no history of pelvic cancer.

Anonymous Patient Answer

Can fallopian tube cancer be cured?

Fallopian tube SCC is a rare, early-stage cancer that is not amenable to cure. However, this illness deserves a full, comprehensive multidisciplinary evaluation to discuss disease and treatment options and provide appropriate prognostic counseling to facilitate the best decision about treatment- options for each patient. Survival rates remain poor for early-stage disease, suggesting that this disease must be treated aggressively, with early detection and referral to a specialist. A multimodal approach involving surgery, chemotherapy, radiotherapy, and possibly immunotherapy should be considered.

Anonymous Patient Answer

What are common treatments for fallopian tube cancer?

Recent findings confirms the superiority of hysterectomy with adnexectomy for [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer), as well as a slight advantage of oophorectomy and chemotherapy for fallopian tube cancer. Further studies are needed to determine the role of other common cancers in fallopian tube cancer.

Anonymous Patient Answer

Is gm-csf safe for people?

It is clear that there are no issues with a small number of adverse events when using Gm-csf. The most common AEs included thrombocytopenia. There is a clear risk of this occurring when Gm-csf is stopped at any stage. This is not only a safety concern but a quality indicator. There would be a clear benefit to patients taking some form of regular Gm-csf. Patients would be able to receive treatment for an average of four more years and treatment is not curative. This is why a small number of AEs are a concern, which is why these events are a part of a bigger study. The most prevalent AEs were transient leukopenia which was reversible.

Anonymous Patient Answer

How quickly does fallopian tube cancer spread?

The prognosis of fallopian tube cancer depends on histologic type. Tumor size at the time of diagnosis correlates with overall survival rate and the degree of tumor spread.

Anonymous Patient Answer

Does fallopian tube cancer run in families?

These data do not support the suggestion that women with Fallopian tube cancer are affected by their family members' disease as compared with a population-based cohort of unaffected controls.

Anonymous Patient Answer

How serious can fallopian tube cancer be?

Fallopian tube cancer is an uncommon but highly lethal malignancy that, due to the absence of clearly effective multimodality therapy, can generally be treated only by cytoreduction or surgery. Because of the rarity of this disease, prospective, randomized, comparative or prospective observational studies are impractical.

Anonymous Patient Answer

What are the chances of developing fallopian tube cancer?

The prevalence of fallopian tube cancer is higher than previously reported, and the [mortality rate for patients is very high(https://www.brit-thorpe.org/library/publications/Fifty_best_journal_lists/50_best_lists_for_gynecologists_and_surgeons/Fallopian_Tubal_Cancer_Rates.pdf).] This information should be considered when counseling patients with a family history of fallopian tube cancer.

Anonymous Patient Answer

What is gm-csf?

GM-csf was not found in any of the tested gynecological malignancies but showed a relatively high prevalence in patients with cervical neoplasias. Because of the limited sample size of endocervical carcinoma no definite conclusion can be drawn regarding GM-csf as a tumor marker.

Anonymous Patient Answer
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