What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Immunotherapy, such as the use of immune checkpoint inhibitors and adoptive cell transfer (similar to AlloStim), can cause side effects like fatigue, skin reactions, diarrhea, and colitis. More severe immune-related adverse events may include pneumonitis, hepatitis, endocrinopathies, and myocarditis. These treatments aim to boost the body's immune response against cancer cells but can also lead to the immune system attacking normal tissues.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of colorectal cancer. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors approved for microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) metastatic colorectal cancer. These drugs work by blocking proteins that prevent the immune system from attacking cancer cells. Additionally, cetuximab (Erbitux) and panitumumab (Vectibix) are anti-EGFR antibodies used in combination with chemotherapy for certain types of colorectal cancer. While these treatments do not directly use immune cells from healthy donors, they stimulate the patient's immune system to target cancer cells.

What other types of research exist?

Promising novel alternatives to AlloStim for colorectal cancer patients include: 1) Immune checkpoint inhibitors like pembrolizumab and nivolumab, which have shown efficacy in certain subsets of colorectal cancer patients, particularly those with high microsatellite instability (MSI-H). 2) CAR-T cell therapy, which is being explored for its potential to target specific cancer antigens. 3) Combination therapies involving immune checkpoint inhibitors and other agents, such as anti-VEGF therapies, to enhance the anti-tumor immune response. 4) Personalized cancer vaccines that stimulate the patient's own immune system to target tumor-specific antigens. These approaches are at various stages of clinical development and may offer new hope for colorectal cancer patients in 2024.

← Back to Search

Cell Therapy

Immunotherapy with AlloStim for Metastatic Colorectal Cancer (STIMVAX Trial)

Phase 2

Recruiting

Research Sponsored by Mirror Biologics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previous treatment failure of two previous lines of active systemic chemotherapy

Presenting with metastatic disease

Must not have

Clinical evidence or radiological evidence of brain metastasis or leptomeningeal involvement

Bowel obstruction or high risk for obstruction if tumors become inflamed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of death from any cause, whichever came first, assessed up to 12 months from accrual

Awards & highlights

No Placebo-Only Group

Summary

This trial tests AlloStim, an immunotherapy using healthy donor immune cells, for patients with advanced colorectal cancer unresponsive to standard treatments. AlloStim helps train the patient's immune system to attack cancer cells by creating a temporary immune response.

Who is the study for?

Adults aged 18-80 with metastatic colorectal cancer that has worsened after two previous chemotherapy treatments can join this trial. They must have an ECOG score of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work. Participants need normal organ function and blood counts, not be pregnant or breastfeeding, agree to use contraception if capable of childbearing, and cannot have certain conditions like brain metastasis or severe heart disease.

What is being tested?

The study is testing AlloStim, an immunotherapy made from healthy donor blood cells. It's for patients whose cancer has spread even after treatment with common chemo regimens (FOLFOX/FOLFIRI) and possibly targeted drugs (anti-EGFR). This Phase IIB trial is open-label at multiple sites where everyone knows what treatment they're getting.

What are the potential side effects?

While specific side effects for AlloStim aren't listed here, similar immunotherapies can cause flu-like symptoms such as fever and chills, fatigue, weakness, nausea, vomiting; potential reactions at the infusion site; allergic reactions; autoimmune responses; or changes in liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had two chemotherapy treatments that did not work.

Select...

My cancer has spread to other parts of my body.

Select...

I am fully active or can carry out light work.

Select...

I am receiving treatment after surgery to prevent cancer return or for cancer that has spread.

Select...

I have been treated with chemotherapy that included oxaliplatin and irinotecan.

Select...

I am between 18 and 80 years old.

Select...

I have KRAS wild type cancer and have been treated with anti-EGFR therapy before.

Select...

I am not pregnant or breastfeeding.

Select...

My diagnosis is colorectal adenocarcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to my brain or its coverings.

Select...

I am at high risk for bowel blockage due to my tumor.

Select...

I have had a bone marrow, stem cell, or organ transplant in the past.

Select...

I need treatment for severe fluid buildup in my abdomen.

Select...

I am unable to give consent for medical procedures by myself.

Select...

I haven't taken high doses of steroids for more than 2 weeks in the last month.

Select...

I have been diagnosed with an autoimmune disease like rheumatoid arthritis.

Select...

I have heart problems that cause symptoms.

Select...

I have severe lung issues needing treatment or my oxygen levels are below 92% without aid.

Select...

I have been diagnosed with HIV/AIDS.

Select...

I am currently fighting a worsening viral or bacterial infection.

Select...

I have symptoms from asthma or COPD.

Select...

I haven't had a fever or taken antibiotics for at least 7 days.

Select...

I have a mood disorder, such as depression or a history of suicidal thoughts or attempts.

Select...

My cancer has spread to the lining of my abdomen.

Select...

My cancer is MSI-H.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of death from any cause, whichever came first, assessed up to 12 months from accrual

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of death from any cause, whichever came first, assessed up to 12 months from accrual

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of death from any cause, whichever came first, assessed up to 12 months from accrual for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidents of Adverse Events (AE)

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AlloStimExperimental Treatment1 Intervention

AlloStim is administered in three cycles: Cycle 1 Day 0: 0.5ml ID AlloStim® Day 7: 0.5ml ID AlloStim® Day 14: 0.5ml ID AlloStim® Day 21: 0.5ml ID AlloStim® Day 28: 0.5ml ID AlloStim® Cycle 2 Day 42: 0.5ml ID AlloStim® Day 49: 0.5ml ID AlloStim® Day 56: 0.5ml ID AlloStim® Day 63: 0.5ml ID AlloStim® Day 70: 0.5ml ID AlloStim® + 3ml IV AlloStim® Cycle 3 Day 84: 0.5ml ID AlloStim® Day 91: 0.5ml ID AlloStim® Day 98: 0.5ml ID AlloStim® Day 105: 0.5ml ID AlloStim® Day 112: 0.5ml ID AlloStim® + 3ml IV AlloStim®

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AlloStim

2016

Completed Phase 2

~90

0 / 25Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as oxaliplatin combined with fluorouracil and leucovorin, works by killing rapidly dividing cancer cells. Targeted therapies, like bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis. Immunotherapy, particularly treatments like AlloStim, leverages immune cells from healthy donors to stimulate the patient's immune system to recognize and attack cancer cells. This approach is significant for colorectal cancer patients as it offers a potential for more personalized and effective treatment by harnessing the body's natural defense mechanisms to combat the disease.

Integration of pharmacology, molecular pathology, and population data science to support precision gastrointestinal oncology.