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

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

NCT ID: NCT02194751

Condition: Follicular Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, Follicular

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Oncoquest-L vaccine
Description: Patients will receive a total of 5 single administrations 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. For each vaccination, a total of 1.0 mL of vaccine will be administered, divided into 2 subcutaneous injections of 0.5 mL each at 2 different injection sites.
Arm group label: Oncoquest-L vaccine

Summary: 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.

Detailed description: This is a single-arm open-label pilot Phase II study. Following informed consent, eligible subjects will undergo excisional biopsy of a lymphoma-containing lymph node for diagnosis and for generation of the Oncoquest-L vaccine. Patients will receive subcutaneous injections consisting of their autologous tumor-derived Oncoquest-L vaccine starting at approximately 4 to 8 weeks after the biopsy. The first two doses will be given at a 2-week interval and the remaining 3 doses at monthly intervals. Patients will be monitored for response by performing imaging studies at baseline and 1 month after the fifth vaccination (Week 19). Additional imaging studies will be performed every 3 months for the first year and every 6 months during the second year until relapse or disease progression whichever occurs sooner.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Follicular lymphoma (FL) grade 1, 2, or 3a diagnosed within 12 months of study enrollment 2. Age ≥ 18 years 3. Previously untreated Stage III or IV FL 4. A single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional biopsy 5. Measurable or evaluable disease after obtaining tissue for vaccine production 6. Performance status (ECOG) of 0 or 1 7. Asymptomatic disease without B symptoms or severe pruritus 8. Low tumor burden as defined by the following criteria: - 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 Exclusion Criteria: 1. Active HIV, hepatitis B, hepatitis C or other active infectious process 2. Pregnant or nursing women 3. Patients with previous history of malignancy within the past 2 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix. 4. Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment 5. Concurrent treatment with immunosuppressive therapy

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Southeastern Regional Medical Center at CTCA

Address:
City: Newnan
Zip: 30265
Country: United States

Contact:
Last name: Karen Rados

Phone: 770-400-6629

Start date: July 2021

Completion date: June 2026

Lead sponsor:
Agency: XEME Biopharma Inc.
Agency class: Industry

Source: XEME Biopharma Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02194751