CLINICAL TRIAL

Cyclophosphamide for Carcinoma

Recruiting · 18+ · All Sexes · Seattle, WA

This study is evaluating whether genetically engineered T cells may help treat patients with triple negative breast cancer, urothelial cancer, or non-small cell lung cancer.

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About the trial for Carcinoma

Eligible Conditions
Lung Neoplasms · Stage IVA Lung Cancer AJCC v8 · Metastatic Ureter Urothelial Carcinoma · Anatomic Stage IV Breast Cancer AJCC v8 · Breast Neoplasms · Carcinoma, Non-Small-Cell Lung · Prognostic Stage IV Breast Cancer AJCC v8 · Stage IVB Lung Cancer AJCC v8 · Carcinoma · Metastatic Lung Non-Small Cell Carcinoma · Metastatic Malignant Solid Neoplasm · Metastatic Triple-Negative Breast Carcinoma · Stage IV Lung Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Cyclophosphamide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
PD1 Inhibitor
BIOLOGICAL
Atezolizumab
DRUG
Cyclophosphamide
DRUG
Fludarabine
DRUG
MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. 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:
Tumor tissue amenable to safe biopsy and subject willing to undergo serial tumor biopsies: Should there be no tumor tissue that is accessible for biopsy, patients will still be considered for participation, at discretion of the sponsor and in consultation with the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons biopsies may be cancelled or retimed after confirming plan with the sponsor Participants must be at least three weeks from last systemic treatment at the time of cell collection: At least 3 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), small molecule or chemotherapy cancer treatment, other investigational agents. There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates are permitted but the concurrent treatment with RANK ligand inhibitors (i.e., denosumab) is not permitted within 8 weeks of treatment
Previous treatment with standard of care (SOC) Food and Drug Administration (FDA)-approved therapies. Patients with NSCLC who have actionable somatic mutations or alterations in EGFR, ROS1 and ALK with FDA-approved drug therapy options will be eligible for study only after treatment with targeted therapies for those mutations have been offered or received. Patients with urothelial carcinoma who are candidates for enfortumab vedotin (enfortumab vedotin-ejfv) will be eligible for study after prior treatment with enfortumab vedotin-ejfv has been offered or received
Previous treatment with PD-1 axis inhibitor: Patients in Phase I/2 must have been offered or been previously treated with at least one dose of a PD-L1 axis inhibitor (e.g. PD-1 or PD-L1 inhibiting monoclonal antibody such as pembrolizumab, nivolumab, avelumab, atezolizumab, durvalumab). If received, they must have either developed progression or still have detectable disease and not have developed Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher toxicity while on treatment. Patients may have received 1 or more prior systemic regimens for metastatic TNBC or NSCLC. There is no upper limit on prior regimens. Patients may have received prior anti-PD-1/anti-PD-L1 in the neoadjuvant or adjuvant setting
HLA type HLA-A*02:01: Participants must be HLA-A*02:01 in order for infused transgenic T cells in order to insure recognition of antigen-MHC complexes. HLA typing should be determined though a molecular approach in a clinical laboratory licensed for HLA typing
The life expectancy of the person must be more than three months at the time of trial entry. show original
is not a problem A problem with fertility is not a problem for those who are willing to comply with the reproductive requirements. show original
= A person with an ECOG performance status of 0 is fully active and has no complaints 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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year post infusion
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year post infusion.
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 Cyclophosphamide will improve 2 primary outcomes and 5 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of 1 year post infusion.

Concentration of transgenic T cells in tumor tissue
1 YEAR POST INFUSION
Objective response rates
1 YEAR POST INFUSION
Evaluated by immune-related RECIST criteria.
Peripheral blood concentration of infused transgenic T cells over time
1 YEAR POST INFUSION
Best overall response
1 YEAR POST INFUSION
Lesions will be separately tracked but response determined in totality. As indicated, patient must have at least one trackable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response will be a defined as best overall response by RECIST 1.1 of complete or partial response.
Incidence of treatment-related unexpected grade 3 or higher adverse events
1 YEAR POST INFUSION
Progression-free survival
1 YEAR POST INFUSION
Will be estimated using the method of Kaplan and Meier.
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Patient Q & A Section

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

What are common treatments for carcinoma?

A substantial number of cancers are cured by treatments. For cancer of the breast the most effective treatment is surgery, while for breast cancer that has spread or is otherwise life-threatening, chemotherapy or hormonal therapy may be effective. For cancer of the oesophagus, no standard treatment may be effective.

Anonymous Patient Answer

What causes carcinoma?

There is still little research being done into the cause of carcinoma. Studies are not enough to reveal the reasons for why some lung cancers occur, and how to prevent, detect and cope with carcinoma. However the risk factors of carcinoma are clear, and knowledge of these risk factors can help prevent and treat lung cancers.

Anonymous Patient Answer

What are the signs of carcinoma?

Symptoms are few, except for advanced liver disease. Most patients presenting with symptoms of an inoperable mass, especially for carcinoma, have advanced liver disease. These patients can be found by screening their risk groups during an outreach cancer screening clinic.

Anonymous Patient Answer

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

Around 180,000 people a year in the United States get carcinoma of the colon, and approximately 80,000 people a year get a cancer in the esophagus.

Anonymous Patient Answer

Can carcinoma be cured?

Despite improved staging accuracy, patient survival rates can still only be obtained by following very specific treatment recommendations. The curative potential of radiobiological treatments for carcinoma has to be further examined in future prospective multicenter studies.

Anonymous Patient Answer

What is carcinoma?

Carcinoma can mean cancer from any tissue; this term is not often used by health science professionals because it can provoke confusion and misgendering. Carcinoma is often associated with an underlying benign tumour. We conclude that the term cancer is the best descriptor to identify most of the cancers with metastatic spread.

Anonymous Patient Answer

What are the latest developments in cyclophosphamide for therapeutic use?

Although its role in treatment of neoplastic disease remains a matter of debate, CTX has gained a reputation as an 'antiinflammatory chemotherapy', which produces significant antitumor effect without significant toxicity to patients. More importantly, no increased risk of leukemia or blast crisis was observed when cyclophosphamide alone or with other noncytotoxic drugs was used in neoplastic disease. There was also no significant reduction in the number of neutrapheresis and hospitalization period that occurred when cyclophosphamide was combined with other drugs.

Anonymous Patient Answer

What is cyclophosphamide?

Findings from a recent study has demonstrated that cyclophosphamide therapy for patients in complete clinical response at the time of secondary surgery may be associated with a low rate of relapse and death, but the time to relapse is longer than expected.

Anonymous Patient Answer

Is cyclophosphamide typically used in combination with any other treatments?

There are several other chemotherapy regimens. However, the majority of the patients received less than two cycles of standard Cyclophosphamide for PDA. This may reflect the retrospective nature of the data and the difficulty in standardization of regimens and dosages in the era of modern chemotherapy. Recent findings reinforce the need for randomized and controlled trials of new agents and regimens.

Anonymous Patient Answer

How does cyclophosphamide work?

We conclude that the anti-tumor effects of 2-CPA are most likely due to the generation of an anti-angiogenic environment as a result of an immunosuppressive action. The mechanism of action of 2-CPA in the induction of tumor cell apoptosis is independent of a direct cell cycle inhibition mechanism.

Anonymous Patient Answer

What is the primary cause of carcinoma?

Carcinoma is a complex entity, with its etiology and mechanisms still under active study. It may develop from malignant neoplastic transformation of epithelial cells, or from non-malignant tumors. Carcinoma may be a multi-factorial, multi-stage process involving both genetic abnormalities and environmental factors.

Anonymous Patient Answer

Is cyclophosphamide safe for people?

Based on our small numbers, patients with no risk factors seem to respond most vigorously to cyclophosphamide. However, people older or with risk factors may require a low-dose cyclophosphamide first-line regimen, whereas low-dose or no cyclophosphamide is likely to be appropriate in frail older patients. There is no evidence that the chemotherapy-induced side effects are increased in frail patients. We discuss these findings within the context of current ethical and clinical judgements.

Anonymous Patient Answer
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