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Oncoquest-L Vaccine for Follicular Lymphoma

This study is testing a vaccine called Oncoquest-L in people with previously untreated Stage III or IV follicular lymphoma (a type of slow-growing blood cancer). The vaccine is made from your own cancer cells and a protein called interleukin-2 (IL-2). Researchers hope it will help your immune system recognize and destroy cancer cells. You might be able to join if you are at least 18 years old, have follicular lymphoma that hasn't been treated before, and have a lymph node that can be biopsied. The main goal is to see how many people have their tumors shrink or disappear after receiving the vaccine. The study is currently recruiting about 30 participants, but its overall status is unclear.

Study design
This is a single-arm, open-label Phase II study, meaning all 30 participants will receive the Oncoquest-L vaccine, and both you and the researchers will know what treatment you are getting.
What's involved
You will have a lymph node biopsy to create the vaccine, then receive 5 injections of Oncoquest-L over approximately 4 months. You will have imaging studies at baseline, after the last vaccine dose, and then every 3-6 months for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for up to 2 years to see how your tumor responds and if your disease progresses.

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NCT02194751

Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma

UNKNOWN
PHASE2Ages 18+InterventionalTreatment
XEME Biopharma Inc.
~30 participants
Updated 2021-04-08 on ClinicalTrials.gov
What's tested:Oncoquest-L vaccine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall tumor response rate
Measured over Up to 2 years

Conditions

Follicular Lymphoma

Explore related trials

Follicular Lymphoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Brion Randolph, MD · PRINCIPAL_INVESTIGATOR · Southeastern Regional Medical Center at Cancer Treatment Centers of America

Who to contact

Karen Rados
[email protected]
770-400-6629
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Normal lactic dehydrogenase
Largest tumor mass \< 7 cm
Involvement of \< 3 nodal sites with a diameter ≥ 3 cm
No clinically significant pleural effusion or ascites
Spleen size of ≤ 16 cm by CT scan
Circulating tumor cells \< 5.0 x 109/L
No clinically significant organ compression 9. Adequate hematopoietic parameters:
Absolute neutrophil count ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 10 g/dL 10. Serum creatinine ≤ 2 x upper limit of normal (ULN) 11. Total bilirubin ≤ 2 x ULN unless considered secondary to Gilbert's syndrome. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 2 x ULN 12. Fertile patients must use effective contraception during and for 12 months after completion of therapy 13. For fertile female patients, a negative pregnancy test result at enrollment

What this trial measures

  • Overall tumor response rateUp to 2 years

    Tumor measurements will be performed at enrollment (baseline); then, tumor measurements and response assessments will occur 4 weeks after the 5th vaccination. Thereafter, tumor measurements and response assessments will occur every 3 months during the 1st year and then every 6 months during the 2nd year until relapse or disease progression, whichever occurs first.