Tocilizumab for Adenocarcinoma

Phase-Based Estimates
1
Effectiveness
2
Safety
University of California, San Francisco, San Francisco, CA
Adenocarcinoma+4 More
Tocilizumab - Drug
Eligibility
18+
Male
Eligible conditions
Adenocarcinoma

Study Summary

This study is evaluating whether a combination of two medications may help treat prostate cancer.

See full description

Eligible Conditions

  • Adenocarcinoma
  • Prostate Cancer
  • Localized Prostate Cancer
  • Prostatic Neoplasms
  • Adenocarcinoma, Prostate

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Tocilizumab will improve 1 primary outcome and 5 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Up to 12 months.

Up to 12 months
Number of treatment-related of adverse events
Proportion of subjects who demonstrate a positive response to neoadjuvant atezolizumab and atezolizumab-based combination therapy for each Cohort of the study
Prostate specific antigen (PSA) response
Rate of Minimal residual disease (MRD)
Rate of Pathologic complete response (pCR) rate
Sum of Pathologic complete response (pCR) and Minimal residual disease (MRD) rate

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

5 Treatment Groups

No Control Group
Cohort A (atezolizumab)

This trial requires 68 total participants across 5 different treatment groups

This trial involves 5 different treatments. Tocilizumab is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohort A (atezolizumab)
Drug
Patients receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP.
Cohort C (atezolizumab, tocilizumab)Patients will receive one (1) cycle of neoadjuvant atezolizumab and one (1) cycle of tocilizumab, 6mg/kg will be administered IV on day 1 of a 14 day IV prior to RP; atezolizumab will be administered in an identical fashion as Cohort A. RP will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP.
Cohort B (atezolizumab, etrumadenant)Patients will receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle and etrumadenant will be taken at a dose of 150mg PO, once daily, until 48 hours prior to RP, for at least 12 days. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP.
Cohort B (atezolizumab, tocilizumab)Patients will receive one (1) cycle of neoadjuvant atezolizumab and one (1) cycle of tocilizumab, 6mg/kg will be administered IV on day 1 of a 14 day IV prior to RP; atezolizumab will be administered in an identical fashion as Cohort A. RP will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP.
Cohort C (atezolizumab, etrumadenant)Patients will receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle and etrumadenant will be taken at a dose of 150mg PO, once daily, until 48 hours prior to RP, for at least 12 days. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrumadenant
2018
Completed Phase 1
~130
Tocilizumab
FDA approved
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for male patients 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:
The diagnosis must be histologically confirmed. show original
Subjects with small cell or neuroendocrine PC are not eligible.\n show original
Patients with high-risk disease are eligible for the safety lead-in for each cohort show original
The study must be conducted in a manner that is consistent with the requirements of the Institutional Review Board. show original
Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy.
a. Deemed by urologic oncology surgeon to be appropriate for a "window-of-opportunity"study.
This study is evaluating whether a combination of a vaccine and a cancer treatment may help prevent cancer in people with an inherited form of the disease. show original
Tumor tissue must be obtained from a biopsy performed at screening show original
Subjects have not received any prior systemic or locally directed therapy for PC). 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.

What are common treatments for adenocarcinoma?

Add answer

This chapter addresses the treatments that are approved for both lung adenocarcinoma and adenocarcinoma of other organs. The treatments are very similar for the two types of cancer.

Unverified Answer

What causes adenocarcinoma?

Add answer

Adenocarcinomas are frequently associated with infection of adjacent tissues and cigarette smoking is a major risk factor for adenocarcinoma. In addition, obesity and diabetes affect adenocarcinoma risk at a statistically significant level.

Unverified Answer

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

Add answer

Adenocarcinoma represents a large portion (25%) of lung cancer diagnoses in the United States. Efforts to increase its detection may not only reduce the number of deaths from lung cancer, but may improve the quality of care that patients receive.

Unverified Answer

What are the signs of adenocarcinoma?

Add answer

Many of the signs are subjective; you may feel that a lump in your breast is too large and painful to be an adenocarcinoma. The most reliable sign of adenocarcinoma is a lump at the mammogram site. [Nipple discharge] is another sign of adenocarcinoma. These symptoms are most similar to infection or breast cancer. [Signs of infection]. There are many [cancerous tumors] associated with [the breast] but do not present with similar characteristics. [Skin tag] are very similar to [cancer], however they present with a different type of presentation. There is a high [grade] of [malignancy] associated with breast adenocarcinoma.

Unverified Answer

What is adenocarcinoma?

Add answer

Adenocarcinoma is a neoplasm (cancer) that affects glandular cells in the lung. It is the most common form of lung cancer in both females and males. Adenocarcinoma forms a large proportion (50%) of lung cancer worldwide. It is also the most common site of lung cancer in the US. The presence of an adenocarcinoma affects patients' ability to respire (breathe). It also has a low survival rate after completion of treatment.

Unverified Answer

Can adenocarcinoma be cured?

Add answer

Adenocarcinoma can be cured in most cases, but there is considerable risk as to recurrence. The number of cases that are cured is high; the risk can be minimized as much as possible through careful preoperative patient selection, complete surgical excision, postoperative adjuvant chemotherapy, and follow-up care.

Unverified Answer

Is tocilizumab safe for people?

Add answer

In a prospective cohort of people receiving tocilizumab for treatment of rheumatoid arthritis, there was evidence of a safety signal with increased rates of SJS/TEN or, very rarely, the SJS/TEN syndrome in both adults and children. At 6 months, there was an increase in hepatitis B reactivation. The most serious adverse event was liver injury; only one case had been reported by 31 September 2015. Toxicity was generally mild and similar to historical non-chemotherapy controls. All cases were attributed to the use of tocilizumab, and no cases were directly attributable to the drug itself.

Unverified Answer

What are the latest developments in tocilizumab for therapeutic use?

Add answer

The development in the field of drug therapy for inflammatory bowel disease has seen the introduction of several new drug classes; the monoclonal antibodies. Tocilizumab has been shown to reduce intestinal inflammation, thus slowing down the disease progression in IBD patients, improving the physical and social function of patients with moderate-to-severe disease activity. Clinical trials have confirmed the safety and efficacy of treatment. It has been approved in the United States in November 2012 for use as an add-on treatment in adults with moderate-to-severe Crohn's disease who fail standard of care therapy, with or without a fistulizing Crohn's disease modifier.

Unverified Answer

What does tocilizumab usually treat?

Add answer

Although tocilizumab is not an effective treatments to treat the symptoms and outcomes of patients with advanced cancer, it can reduce the complications and shorten the duration of chemotherapy, thus alleviating the treatment-associated side effects on the patients, and improving their quality of life.\n

Unverified Answer

What are the common side effects of tocilizumab?

Add answer

Commonly reported side effects associated with tocilizumab monotherapy or combination therapy include injection site reactions, fatigue, headache, nausea, and abdominal pain. Although a causal relationship connecting tocilizumab exposure to these events can not be determined, patients should be warned about these side effects as they occur in more than a third of patients. If patients experience these events, they should seek immediate medical attention.

Unverified Answer

Has tocilizumab proven to be more effective than a placebo?

Add answer

Compared to a placebo, TIVAE seems to result in similar improvement of patients with symptomatic advanced adenocarcinoma of the pancreas in overall survival or in those in a high performance status. The improvement of symptoms seems associated with a longer survival. Better results might be achieved in patients with a high CD8+ T-lymphocyte count.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Adenocarcinoma by sharing your contact details with the study coordinator.