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

NCT02194751 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: X13-21008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of complete and partial tumor response rates

  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)

  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

  From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination.

Study Arms (1)

Oncoquest-L vaccine

EXPERIMENTAL

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

Interventions

Oncoquest-L vaccine BIOLOGICAL

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.

Oncoquest-L vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Follicular lymphoma (FL) grade 1, 2, or 3a diagnosed within 12 months of study enrollment
• Age ≥ 18 years
• Previously untreated Stage III or IV FL
• 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
• Performance status (ECOG) of 0 or 1
• Asymptomatic disease without B symptoms or severe pruritus
• 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

You may not qualify if:

• Active HIV, hepatitis B, hepatitis C or other active infectious process
• Pregnant or nursing women
• 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.
• Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
• Concurrent treatment with immunosuppressive therapy

Sponsors & Collaborators

• XEME Biopharma Inc.: lead

Study Sites (1)

Southeastern Regional Medical Center at CTCA

Newnan, Georgia, 30265, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Brion Randolph, MD

  Southeastern Regional Medical Center at Cancer Treatment Centers of America

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Rados

CONTACT

770-400-6629; Karon.Rados@ctca-hope.com

Mittie Mitchell, RN

CONTACT

770-400-7194; Mittie.Mitchell@ctca-hope.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 18, 2014
• Study Start: July 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2026
• Last Updated: April 8, 2021

Record last verified: 2020-07

Locations

US (1)