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GVAX for Colorectal Cancer

Phase 1
Waitlist Available
Led By Cristina Ferrone, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically documented hepatic colorectal cancer metastasis with resectable hepatic lesions
At least 4 weeks since last dose of chemotherapy, radiotherapy, immunotherapy, systemic glucocorticoid therapy or operation in order to receive vaccine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is a study to see if it is safe to give a vaccine made from a person's own colorectal cancer cells. The study will also look at if the vaccine has any effect, good or bad, on the cancer returning after the person has surgery to remove the cancer from their liver.

Eligible Conditions
  • Colorectal Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients Who Fail to Receive the First Six Scheduled Vaccinations Because of Toxicity
Secondary outcome measures
Immune Response
Progression Free Survival
Two Year Survival

Side effects data

From 2018 Phase 1 & 2 trial • 29 Patients • NCT01696877
86%
Injection site reaction
71%
Urinary Incontinence
57%
Premature menopause
50%
Erectile dysfunction
43%
Allergic reaction
21%
Fatigue
21%
Fever
21%
Arthralgia
14%
Cystitis noninfective
14%
Abdominal pain
14%
Peripheral sensory neuropathy
7%
Allergic rhinitis
7%
Hematoma
7%
Urinary tract infection
7%
Stroke
7%
Creatinine increased
7%
Aspartate aminotransferase increased
7%
Diarrhea
7%
Blood bilirubin increased
7%
Lethargy
7%
atrial fibrillation
7%
Atrial flutter
7%
Weight gain
7%
Headache
7%
Facial nerve disorder
7%
Insomnia
7%
Generalized muscle weakness
7%
Restlessness
7%
Anxiety
7%
Oral dysesthesia
7%
Eye disorders - Other,
7%
Alanine aminotransferase increased
7%
Anemia
7%
Hypertriglyceridemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cyclophosphamide, GVAX and Degarelix
Degarelix

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental Treatment ArmExperimental Treatment1 Intervention
GVAX, up to 6 vaccinations, administered via injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GVAX
2015
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,834 Total Patients Enrolled
Cristina Ferrone, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
3,500 Total Patients Enrolled

Frequently Asked Questions

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

Is recruitment still underway for this trial?

"Affirmative. According to the clinicaltrials.gov website, this research is actively recruiting participants as of now. This project was initially posted on July 1st 2013 and its details were last amended on January 4th 2018; 15 individuals are being sought after by one location for enrolment in the trial."

Answered by AI

What potential risks has GVAX been known to pose for individuals?

"GVAX's safety rating is 1 given that this Phase 1 trial has limited data regarding its effectiveness and security."

Answered by AI

To what extent has the populace participated in this experiment?

"Affirmative. Clinicaltrials.gov displays that this medical research is presently looking for participants, having been initially advertised on the 1st of July 2013 and last modified on 4th January 2018. 15 subjects are required between a single site."

Answered by AI
~0 spots leftby Mar 2025