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Cancer Vaccine
Oncoquest-L Vaccine for Follicular Lymphoma
Phase 2
Waitlist Available
Led By Brion Randolph, MD
Research Sponsored by XEME Biopharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional biopsy
Measurable or evaluable disease after obtaining tissue for vaccine production
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying a vaccine made from a patient's own cancer cells and interleukin-2, given under the skin, to see if it can help the patient's immune system destroy the cancer cells.
Who is the study for?
This trial is for adults with a recent diagnosis of Stage III or IV follicular lymphoma, who haven't been treated yet. They should have low tumor burden, be in good physical condition, and not show severe symptoms. Pregnant women, those on immunosuppressants, or with active infections like HIV can't join.Check my eligibility
What is being tested?
The Oncoquest-L vaccine is being tested to see if it helps the immune system fight cancer by using the patient's own cancer cells mixed with IL-2 protein. The study will check how well tumors respond and monitor safety and time until other treatments are needed.See study design
What are the potential side effects?
While specific side effects aren't listed here, vaccines like this could cause reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, muscle aches or possibly allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a lymph node that is big enough and can be surgically removed for testing.
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My disease can be measured or evaluated after tissue collection for vaccine production.
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My condition is Stage III or IV follicular lymphoma and I haven't received treatment.
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I am fully active or can carry out light work.
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My condition does not cause me severe itching or B symptoms like fever.
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I am a woman able to have children and my pregnancy test before joining the study was negative.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall tumor response rate
Secondary outcome measures
Assessment of complete and partial tumor response rates
Assessment of time until initiation of radiotherapy or systemic therapy
Safety evaluation will include frequency, severity, and relationship of adverse events to vaccination; vital signs (blood pressure, respiration, pulse, and temperature); and laboratory test results (including, hematology and clinical chemistry)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Oncoquest-L vaccineExperimental Treatment1 Intervention
Patients will receive a total of 5 single injections of Oncoquest-L; the first 2 doses administered will be separated by a 2-week interval and the remaining 3 doses will be administered each at 1-month intervals. With each dose of Oncoquest-L vaccine, the vaccine will be administered subcutaneously at 2 different sites in the upper arms or upper legs, with alternation of the injection sites with each administration.
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Who is running the clinical trial?
XEME Biopharma Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Brion Randolph, MDPrincipal InvestigatorSoutheastern Regional Medical Center at Cancer Treatment Centers of America
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lymph node that is big enough and can be surgically removed for testing.My disease can be measured or evaluated after tissue collection for vaccine production.I do not have active HIV, hepatitis B, hepatitis C, or other infections.I haven't had cancer in the last 2 years, except for certain skin cancers or cervical cancer that were completely treated.I was diagnosed with a type of lymphoma called follicular lymphoma within the last year.My condition is Stage III or IV follicular lymphoma and I haven't received treatment.I am fully active or can carry out light work.My condition does not cause me severe itching or B symptoms like fever.My cancer has not spread extensively.My blood counts are within a healthy range.I am a woman able to have children and my pregnancy test before joining the study was negative.I am currently on immunosuppressive therapy.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Oncoquest-L vaccine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What possible side effects could the Oncoquest-L vaccine have?
"While Phase 2 trials give some indication of a treatment's safety, there is no data supporting efficacy. Therefore, Oncoquest-L vaccine scores a 2."
Answered by AI
Are volunteers still being recruited for this experiment?
"This study, which was last updated on April 7th 2021 appears to be inactive according to clinicaltrials.gov. Although this specific trial is not looking for candidates, there are 1,761 other studies that have open recruitment at the moment."
Answered by AI
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