Back to resultsOncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma
Primary Purpose
Follicular Lymphoma
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oncoquest-L vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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
Adequate hematopoietic parameters:
- Absolute neutrophil count ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 2 x upper limit of normal (ULN)
- Total bilirubin ≤ 2 x ULN unless considered secondary to Gilbert's syndrome. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 2 x ULN
- Fertile patients must use effective contraception during and for 12 months after completion of therapy
- For fertile female patients, a negative pregnancy test result at enrollment
Exclusion Criteria:
- 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
Sites / Locations
- Southeastern Regional Medical Center at CTCA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oncoquest-L vaccine
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Assessment of time until initiation of radiotherapy or systemic therapy
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02194751
Brief Title
Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma
Official Title
Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XEME Biopharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oncoquest-L vaccine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Oncoquest-L vaccine
Intervention 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.
Primary Outcome Measure Information:
Title
Overall tumor response rate
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Assessment of complete and partial tumor response rates
Description
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.
Time Frame
Up to 2 years
Title
Assessment of time until initiation of radiotherapy or systemic therapy
Time Frame
Up to 2 years
Title
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)
Description
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.
Time Frame
From the time of informed consent up to 2 years
Title
Tests to measure tumor-specific antibody production and T cell and B cell responses to vaccination
Description
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.
Time Frame
From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Adequate hematopoietic parameters:
Absolute neutrophil count ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 10 g/dL
Serum creatinine ≤ 2 x upper limit of normal (ULN)
Total bilirubin ≤ 2 x ULN unless considered secondary to Gilbert's syndrome. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 2 x ULN
Fertile patients must use effective contraception during and for 12 months after completion of therapy
For fertile female patients, a negative pregnancy test result at enrollment
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Rados
Phone
770-400-6629
Email
Karon.Rados@ctca-hope.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mittie Mitchell, RN
Phone
770-400-7194
Email
Mittie.Mitchell@ctca-hope.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brion Randolph, MD
Organizational Affiliation
Southeastern Regional Medical Center at Cancer Treatment Centers of America
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeastern Regional Medical Center at CTCA
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Rados
Phone
770-400-6629
12. IPD Sharing Statement
Learn more about this trial
Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma
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