Cyclophosphamide for Adenocarcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Fred Hutch/University of Washington Cancer Consortium, Seattle, WA
Adenocarcinoma+2 More
Cyclophosphamide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Adenocarcinoma

Study Summary

This study is evaluating whether a new type of T cell therapy may help treat pancreatic cancer.

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Eligible Conditions

  • Adenocarcinoma
  • Stage IV Pancreatic Cancer AJCC v8
  • Metastatic Pancreatic (Ductal) Adenocarcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Cyclophosphamide will improve 2 primary outcomes and 3 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Up to 1 year after the last T cell infusion.

Year 1
Overall response rate
Overall survival
Progression free survival
Day 14
Dose limiting toxicities
Week 4
Incidence of adverse events

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Cohorts I, II, and III (FH-TCR Tᴍsʟɴ)

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cyclophosphamide 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 1 and are in the first stage of evaluation with people.

Cohorts I, II, and III (FH-TCR Tᴍsʟɴ)LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days 39-41. T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.
Cohort IV (FH-TCR Tᴍsʟɴ)LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -3 to -1. T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 14 days after each t cell infusion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 14 days after each t cell infusion for reporting.

Closest Location

Fred Hutch/University of Washington Cancer Consortium - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Adenocarcinoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, including chemotherapy, antibodies, or small molecule inhibitors Patients may have received prior chemotherapy, antibodies, or small molecule inhibitors for metastatic disease. show original
At trial entry, the life expectancy of the patient must be more than three months. show original
, an individual must be able to read, understand, and communicate in English show original
initiation The required waiting period before enrolling in this study is 3 weeks since the participant has stopped receiving any: immunotherapy, small molecule or chemotherapy cancer treatment, or other investigational agents show original
ECOG performance status is a measure of how active a person is in their cancer treatment show original
material The patient must have two measurable lesions and the baseline imaging must be obtained within 28 days prior to the start of the first planned FHMSLN-TCR infusion show original
Tissue confirmation of pancreatic ductal adenocarcinoma and expression of mesothelin (MSLN): Participants must have metastatic disease. Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at Fred Hutchinson Cancer Research Center (FHCRC)/University of Washington (UW). Baseline tissue will be stained by immunohistochemistry (IHC) to confirm MSLN expression
Human leukocyte antigen (HLA) type HLA-A*02:01: Participants must be HLA-A*02:01 in order for the infused transgenic T cells to recognize antigen-major histocompatibility complex (MHC) complexes on their tumor. HLA typing should be determined though a molecular approach in a clinical laboratory licensed for HLA typing
Tumor tissue amenable to safe biopsy and subject willing to undergo serial tumor biopsies at baseline (prior to first T cell infusion), 3 weeks (prior to second T cell infusion), and 8 weeks +/- 1 week after the first T-cell infusion (approximately 2 weeks +/- 1 week weeks after the 3rd infusion), if safe and feasible: Should there be no tumor tissue that is accessible for biopsy, patients will still be considered for participation, at discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons, biopsies may be cancelled or rescheduled
/1.73m2 If someone's serum creatinine level is below 1.5 times the upper limit of normal, or if their estimated glomerular filtration rate is above 60 mL/min/1.73m2, they are considered to have normal kidney function. show original

Patient Q&A Section

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

Can adenocarcinoma be cured?

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Adenocarcinoma can be cured when it is detected in its early stages. However, as in any form of cancer, treatment must be targeted to the specific subtype of adenocarcinoma of the pancreas.

Unverified Answer

Has cyclophosphamide proven to be more effective than a placebo?

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Results from a recent clinical trial has shown no significant difference of the effects between low-dose oral prednisone and cyclophosphamide on delaying and preventing the resolution of acute GVHD after allogeneic BMT.

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What are common treatments for adenocarcinoma?

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Common treatments for adenomas include endoscopic resection, endoscopic mucosal resection, or surgery. Treatment options include chemo or chemoradiation therapy. In the case of adenocarcinoma, treatment commonly centers around surgery as well as the use of radiation and/or chemo therapy. The advent and popularity of immunotherapy is increasing annually. There is also growing evidence for the use of photodynamic therapy to be a safe and effective treatment in some adenocarcinomas that are resistant to other options.

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How many people get adenocarcinoma a year in the United States?

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Adenocarcinoma of the lung is an increasingly common lung cancer in the U.S., and has been diagnosed almost as frequently as in 1990. In addition, cigarette smoking, particularly in combination with other risk factors, plays an important role in the development of lung adenocarcinoma.

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What is adenocarcinoma?

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Adenocarcinoma is one of two histologic subtypes of lung cancer. In the United States, it is the eighth most common form of lung cancer. Adenocarcinoma causes a significant number of deaths (about 2250 deaths in the US per year). Adenocarcinoma cases include bronchioloalveolar, alveolar, acinar, papillary, squamous, sarcomatoid, adenosquamous and micropapillary variants.

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What are the signs of adenocarcinoma?

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Symptoms of adenocarcinoma are often present, but often subtle and non-specific. Some symptoms, such as weight loss and anemia, may be present regardless of the cause of the abdominal pain. Painless adenocarcinoma can lead to a diagnostic error.

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How serious can adenocarcinoma be?

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In the opinion of an experienced general surgeon, adenocarcinoma seems more aggressive than SCC; when only a limited number of prognostic factors are considered (sex, age, stage, and grade), the difference is not statistically significant, but is substantial clinically. If a multicenter trial confirms these results, then the need for large-scale, multi-institutional clinical trials should be reconsidered.

Unverified Answer

How does cyclophosphamide work?

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Cyclophosphamide works by increasing the proliferation of the target cells and the subsequent generation of G2/M cells in SCC. The increased toxicity of this agent may in turn increase the number of cells in SCC, which may allow the cells to survive the toxic effects of the drug. Thus, cyclophosphamide may have a new treatment role in SCC.

Unverified Answer

What is the primary cause of adenocarcinoma?

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Adenocarcinoma is diagnosed in 1 in 300 patients seen in oncology clinics. The primary cause of adenocarcinoma is unknown in 50% of patients and is likely related to environmental carcinogens.

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What does cyclophosphamide usually treat?

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Cyclophosphamide does not normally cure patients with Hodgkins disease. This drug can often give relief from some of the symptoms of a [Hodgkins disease]]; however, the patient is usually able to manage the side effects as long as they take the drug on a regular basis. Symptoms such as fever, sore eyes, painful/tender cheeks, swelling, [vomiting], achiness, itching, fatigue etc often disappear. Therefore, cyclophosphamide treatment can also be used as maintenance therapy or to treat the disease in relapse, especially in those patients [HIV positive] who carry Hodgkins disease as well as those patients who have relapsed after previous therapies.

Unverified Answer

How quickly does adenocarcinoma spread?

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After an average diagnosis time of 10.5 months, the tumor had spread to nearby lymph nodes. Tumor metastasis occurred in 26% of local failures but did not influence distant recurrence. Early tumor detection with early intervention by a surgeon might reduce local recurrence.

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