Hydroxychloroquine for Cancer of Pancreas

Phase-Based Estimates
1
Effectiveness
1
Safety
Huntsman Cancer Institute/University of Utah, Salt Lake City, UT
Cancer of Pancreas+8 More
Hydroxychloroquine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

This study is evaluating whether hydroxychloroquine may help improve the effectiveness of trametinib in treating pancreatic cancer.

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Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms
  • Carcinoma
  • Unresectable Pancreatic Carcinoma
  • metastatic pancreatic endocrine carcinoma
  • Stage III Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Stage IV Pancreatic Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Hydroxychloroquine will improve 1 primary outcome and 2 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of At 28 days.

Day 30
Incidence of adverse events (AEs) for the duration of study treatment
5 years
Response Rate
At 28 days
Rate of dose-limiting toxicities during the DLT assessment window.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (trametinib, hydroxychloroquine)

This trial requires 33 total participants across 2 different treatment groups

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

Treatment (trametinib, hydroxychloroquine)Patients receive trametinib PO QD on days 1-28 and hydroxychloroquine PO QD or BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
FDA approved
Trametinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

Huntsman Cancer Institute/University of Utah - Salt Lake City, UT

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Platelet count >= 100 x 10^9/L
Hemoglobin >= 9 g/dL
Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range
Subject with histologically confirmed metastatic or locally advanced, unresectable pancreatic carcinoma
Subject is willing to provide a baseline biopsy.
EXPANSION COHORT ONLY: Subject must have progressed during or after two standard of care lines of treatment or refused standard of care options.
Subject must have computed tomography (CT) measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Subject must be able and willing to undergo disease assessment while on study and afterwards, if removed for reason other than progression
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

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 cancer of pancreas be cured?

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There is no cure for [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) today (2013), however, it is treatable. The best chance of survival relies on the size of tumors, type and stage of the cancer, and the person's overall overall health. Current treatment is similar in its effectiveness to treatment that gave good results in the past. People with advanced pancreatic cancer with a prognosis of a year or more can be treated in trials. Other trials of treatments can be conducted for people with [cancer of pancreatic head and body], or unresectable pancreatic cancer. For people with pancreas cancer, [Power (https://www.withpower.com/d/cancer-patient-information) websites] offer information and treatment options.

Unverified Answer

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

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The disease was more common in African Americans (24.7) and Hispanics (22.2) than whites (12.7) and Asian Americans (16.1), although the absolute number of new cases was nearly three-and-a-half times greater among whites (1,874 cases a year) than in African Americans (488 cases a year) or Hispanics (452 cases a year). The differences in incidence could be explained by the lifestyle and demographic characteristics of these populations. Cancer of pancreas was second only to [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) among cancers diagnosed in the year 2000 and among men aged 40 to 69, was second only to lung cancer for deaths from cancer.

Unverified Answer

What are common treatments for cancer of pancreas?

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Most studies show that adjuvant chemoradiotherapy is a common and effective treatment for PDAC. Chemotherapy consists in an initial combination of fluoropolymer and oxaliplatin followed by the addition of mitoxantrone with 5-FU. Patients with early stage disease and low grade tumors are treated with surgical resection followed by postoperative adjuvant therapy. Post-surgical treatment consists in concurrent combination of oxaliplatin and bevacizumab with concurrent gemcitabine, irinotecan and carboplatin. There are a number of clinical trials that try to define the superiority of surgery versus definitive and palliative CT.

Unverified Answer

What are the signs of cancer of pancreas?

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The patient should remember to have more frequent medical checkups to detect malignancy of pancreas. The most important sign for early diagnosis of malignancy is the change in the stool in the last two months. The patient should not have any medical reason to be in hospital on or around the last two months. The patients with malignant disease should always be encouraged for surgical removal of the cancer. The patient with malignant mass or abdominal pain is to be hospitalized for further evaluation. It is to be remembered that endoscopy and biopsy techniques can be useful in early diagnosis of malignancy of pancreas as a cause of abdominal pain or weight loss.

Unverified Answer

What causes cancer of pancreas?

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The risk of developing [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) increases with age. Men and women appear to have a similar age of onset. The most frequent type of cancer is adenocarcinoma, which accounts for 86% of the reported cases. Alcohol is the main risk factor in this region of the world. The risk is approximately twice for male and female patients. Other risk factors include a family history and obesity. The use of radiotherapy may increase the risk of pancreatic cancer. Smoking, particularly in combination with diabetes, is associated with a higher risk of cancer of the pancreas, as has drinking alcohol.

Unverified Answer

What is cancer of pancreas?

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This is the most common type of cancer that forms in the exocrine pancreas. Cancer of the pancreas forms in the pancreas. It is a disease from that affects the endocrine part of the pancreas. Types include pancreatic adenocarcinoma, adenosquamous carcinoma of the pancreas, neuroendocrine carcinoma, and sarcomatoid carcinoma. It is generally hard to diagnose because it lacks the appearance of the mass of the pancreas so checking for it for signs such as nausea, vomiting, unexplained weight loss, diarrhea, constipation, and in some cases abdominal pain, jaundice, and dark urine.

Unverified Answer

Does cancer of pancreas run in families?

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Results from a recent clinical trial has made a significant contribution to the knowledge on cancer in families, as an association of the family members might not be obvious. A screening of the tumor-related genes such as the MUTYH gene can be helpful in early diagnosis. Further study of the carcinogenic mechanisms in the families is needed to provide a basis for the management of these patients. This will be useful to the future doctors and the patients for early diagnosis of the cancer.

Unverified Answer

What is the latest research for cancer of pancreas?

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Cancer of pancreas may be found in any age and has an average survival time of only six to eight months, which is very short when compared to other cancers. Because cancer of pancreas is very rare, there are very few research studies done for this particular type of cancer and also very few doctors practicing in these areas are experts in cancer of pancreas. Therefore, no specific treatment is available for any form of cancer of pancreas at the present time, or even available for the patients to receive.

Unverified Answer

Have there been other clinical trials involving hydroxychloroquine?

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The only other randomized controlled trial that has been published is with hydroxychloroquine alone, involving only two medications (pentoxifylline and hydroxychloroquine), compared to placebo plus standard therapy. Recent findings of this trial had an unacceptable number of septic complications, causing the authors to rethink their design. Although hydroxychloroquine alone has been studied, the results were never published. Thus, when considering the future of clinical trials of hydroxychloroquine alone, these results should be taken into account. The authors recommend that clinical trials of hydroxychloroquine should be performed under the guidelines and guidelines for the treatments of this rare condition.

Unverified Answer

What are the latest developments in hydroxychloroquine for therapeutic use?

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The first published report of therapeutic use of hydroxychloroquine in cutaneous disease was in 1980. Since then, the drug has been studied widely and reported to be effective. This is due not only to its anti-microbial qualities, but also from its immuno-modulatory and anti-inflammatory properties, with beneficial effects on skin diseases such as ulcerative colitis, rheumatoid arthritis and psoriasis, as well as acne and psoriatic arthritis. Studies also suggest that hydroxychloroquine might be effective in treating autoimmune disorders, such as systemic lupus erythematosus and psoriatic arthritis.

Unverified Answer

Does hydroxychloroquine improve quality of life for those with cancer of pancreas?

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Although no difference between groups was seen in the quality of life questionnaire scores, the results demonstrate that the treatment is well-tolerated for this population with different stages of disease. More research should be done to investigate more detailed quality of life questionnaires and treatment in this population. Randomized controlled trials seem feasible.

Unverified Answer

How quickly does cancer of pancreas spread?

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Based on the results of the current studies, we can say that the average (median), of the patients with [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) who died within 6 months after the diagnosis, the average distance of the cells had the tendency of spread out of the pancreas within 6 months. Most of the patients developed the cancer of the pancreas in the third to sixth month, and as the disease progressed, doctors started to diagnose people with cancer of the pancreas before they were discharged from the hospital, so they have a good chance of finishing off the disease within 6 months after the initial diagnosis. However, in the end, a small number of patients continued to keep up the disease in the following 9 to 12 month, and died sooner.

Unverified Answer
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