Oncoquest-L Vaccine for Follicular Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byBrion Randolph, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: XEME Biopharma Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This Phase II trial studies the overall tumor response of vaccine therapy in patientswith previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The vaccine contains an extract of the patient's own cancer cells and the immunostimulant protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine will enable the patient's immune system to recognize and destroy the cancer cells. The trial will also assess the safety of the vaccine, the time from vaccine treatment until the patient requires another type of anti-lymphoma treatment, progression-free survival, and the anti-tumor immune response.

Eligibility Criteria

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.

Inclusion 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.

Fertile patients must use effective contraception during and for 12 months after completion of therapy

+8 more

Exclusion Criteria

Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment

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.

+2 more

Participant Groups

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.

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.