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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Follicular Lymphoma
• Intervention / Treatment: Biological: Oncoquest-L vaccine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mittie Mitchell, RN; Phone Number: 770-400-7194; Email: Mittie.Mitchell@ctca-hope.com
• Study Contact Backup: Name: Karen Rados; Phone Number: 770-400-6629; Email: Karon.Rados@ctca-hope.com

Study Locations

• United States
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center at CTCA
      • Contact: Karen Rados; Phone Number: 770-400-6629

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oncoquest-L vaccine; 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.

Biological: Oncoquest-L vaccine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall tumor response rate	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.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of complete and partial tumor response rates	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.	Up to 2 years
Assessment of time until initiation of radiotherapy or systemic therapy		Up to 2 years
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)	Safety parameters (e.g., adverse events, vital signs, and laboratory test results) will be recorded from the time patient signs informed consent, at every clinic visit during study treatment, 4 weeks after the 5th vaccination, and thereafter every 3 months during the 1st year and then every 6 months during the 2nd year.	From the time of informed consent up to 2 years
Tests to measure tumor-specific antibody production and T cell and B cell responses to vaccination	Antibody production will be reported as increased titers of antibodies, B cells will be expressed as % B cell populations, T cell responses will be expressed as increases of tumor-specific T cells and changes in expression and quantity of cytokines (proteins that indicate changes in the immune response). Blood samples will be collected within 8 weeks prior to the 1st vaccination (baseline); within 7 days prior to the 5th vaccination; and 4 weeks after the 5th vaccination.	From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination.

Collaborators and Investigators

• Sponsor: XEME Biopharma Inc.
• Investigators: Principal Investigator: Brion Randolph, MD, Southeastern Regional Medical Center at Cancer Treatment Centers of America

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular
• Other Study ID Numbers: X13-21008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No