Cyclophosphamide for Cancer of Pancreas

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Cancer of Pancreas+2 More
Cyclophosphamide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can be safely given to pancreatic cancer patients after surgery.

See full description

Eligible Conditions

  • Cancer of Pancreas
  • Malignant Neoplasm of Pancreas

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer of Pancreas

Study Objectives

This trial is evaluating whether Cyclophosphamide will improve 1 primary outcome and 2 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of 4 years.

4 years
Number of participants with adverse events as a measure of toxicity
Survival
Time to disease progression using immune correlates

Trial Safety

Safety Progress

1 of 3

Other trials for Cancer of Pancreas

Trial Design

2 Treatment Groups

Cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX
1 of 2
SBRT and FOLFIRINOX
1 of 2
Experimental Treatment

This trial requires 19 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 not being studied for commercial purposes.

Cyclophosphamide, Vaccine, SBRT, and FOLFIRINOXThe last 12 patients will receive cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX.
SBRT and FOLFIRINOXThe first 6 patients will receive SBRT and FOLFIRINOX only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fluorouracil
FDA approved
Stereotactic Body Radiation (SBRT)
2014
Completed Phase 2
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Closest Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Documented cancer of the pancreas (head, neck, and/or uncinate process), that has been completely resected
No prior Chemotherapy, radiation therapy or biologic therapy for pancreatic cancer
Must be within 10 weeks from surgical resection of cancer
Titanium clips (minimum 1) must be placed at the time of surgery to aid in SBRT treatment planning
ECOG Performance Status of 0 to 1
Adequate organ function as defined by study-specified laboratory tests
Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
Signed informed consent form
Willing and able to comply with study procedures

Patient Q&A Section

What are the signs of cancer of pancreas?

"Patients with cancer of pancreas should be investigated with diagnostic tests to detect any early cancer of pancreas. For early detection, the use of endoscopic ultrasound, biopsy, or fine needle aspiration should be encouraged." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer of pancreas?

"Chemotherapy is the only possible curative treatment for the majority of the patients with [pancreas cancer](https://www.withpower.com/clinical-trials/pancreas-cancer), but it is possible to cure more patients based only on surgery. The most important of all treatments is cancer-specific counseling and education for patients and their family. There are many kinds of cancer treatments. But for patients with pancreas cancer, it is possible to manage these patients by using the treatments that are based on disease stage before diagnosis, surgery and other treatments." - Anonymous Online Contributor

Unverified Answer

Can cancer of pancreas be cured?

"Cancer of pancreas can be highly curable or fatal depending on the stage of the disease and the extent of the cancer at the time of cancer diagnosis." - Anonymous Online Contributor

Unverified Answer

How many people get cancer of pancreas a year in the United States?

"About 40,000 Americans get [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) a year. Diabetes appears to increase the risk for malignancy, but it is not associated with any significant increase in risk of other types of cancer." - Anonymous Online Contributor

Unverified Answer

What is cancer of pancreas?

"Pancreatic cancer accounts for less than 3% of all solid cancers. It is very rare in children. Older individuals are more prone to develop pancreatic cancer. The 5-yr survival is 35%. The most frequent site of cancer in the pancreas is head of pancreas (72%) and then in the body region (16%), followed by distal bile ducts (8%), and then the tail (5%)." - Anonymous Online Contributor

Unverified Answer

What causes cancer of pancreas?

"The cause of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) remains unknown. It is thought that cancer can develop in the pancreas due to genetic factors, exposure to cancer-causing toxins or hormones, lifestyle factors, immunological factors and environmental factors." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for cancer of pancreas?

"We conclude that curative radical surgery is the most efficient therapy for localized tumours but has limited usefulness if the tumour is highly invasive or metastatic. The latter has a dismal prognosis without any treatment. The survival rate, particularly after metastasis has been reported in literature to be high, indicating intensive surgery. There is a need to study the biological and epidemiological mechanisms of the high rate of metastasis in pancreas." - Anonymous Online Contributor

Unverified Answer

What is cyclophosphamide?

"On average cyclophosphamide treats more patients safely than many conventional cytotoxic agents. Unlike some cytotoxic agents that have a narrow therapeutic index, cyclophosphamide has an extremely low toxicity profile and is often considered a first-line treatment for breast cancers.. Cyclophosphamide is used in treatment of many other hematological malignancies and also in non-malignant disorders such as autoimmune and inflammatory diseases.. The following is a partial list of clinical trial trials in which cyclophosphamide is used in treatment of various disease indications. For cyclophosphamide pharmacology, see Cyclophosphamide." - Anonymous Online Contributor

Unverified Answer

Is cyclophosphamide typically used in combination with any other treatments?

"For patients with advanced or metastatic pancreatic adenocarcinoma, cyclophosphamide combined with a number of other agents, including mitomycin, ifosfamide, etoposide, doxorubicin and vincristine was found to be effective, but with greater toxicity in a phase IIb trial with intent to replace conventional cyclophosphamide-based regimens (and may not be effective against non-metastatic disease). Results from a recent clinical trial of this study also indicate that for this specific patient population, the conventional CHOP regimen has a very high rate of early and late toxicity." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer of pancreas?

"A significant number of studies have been conducted in the last 5 years to develop effective ways for detecting and treating diabetes. Current research aims at developing new methods to diagnose, assess, and treat [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer). Diabetes research also aims at developing better methods of detection and treatment. In this context, the European Diabetes Research Programme (EDRP) will be involved in the European project, [EUROCAN] (https://www.eurocanprogram.eu/). The EUROCAN project is focused on the development of new effective tools and techniques for early cancer detection. Such techniques are aimed at improving the diagnostic process of pancreatic cancer by increasing the detection rate of pancreatic tumors." - Anonymous Online Contributor

Unverified Answer

How does cyclophosphamide work?

"Although most patients are managed non-pharmacologically, cyclophosphamide monotherapy (single agent) has been an important chemotherapeutic approach in the treatment of EAC over the past 35 years, as evidenced by our institutional experience with treatment results, response rates, and survival as well as published series. This approach to treatment has proven to be safe and durable with only moderate toxicities. The optimal approach and timing and duration of chemo therapy remains to be determined." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing cancer of pancreas?

"There is a higher rate of disease recurrence and lower survival for PCa compared to BPCa and the incidence of PCa is [1.0% compared to 0.7% and 0.3% of BPCa] per 100 patient/year. PCa is also more [disease-specific] mortality for both men and women than BPCa. The incidence of PCa in this study [is 8.8/100,000 person-years-1,000] is higher than the reported incidence of PCa in China [3.3/100,000 person-years-1,000] and may not be the same as the incidence reported in many developed countries." - Anonymous Online Contributor

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