Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
X13-21008
- NCT ID:
NCT02194751
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Oncoquest-L vaccine | | Oncoquest-L vaccine |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall tumor response rate |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| 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. |
Secondary Outcome Measures
| Measure: | Assessment of complete and partial tumor response rates |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| 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. |
| Measure: | Assessment of time until initiation of radiotherapy or systemic therapy |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | 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) |
| Time Frame: | From the time of informed consent up to 2 years |
| Safety Issue: | |
| 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. |
| Measure: | Tests to measure tumor-specific antibody production and T cell and B cell responses to vaccination |
| Time Frame: | From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination. |
| Safety Issue: | |
| 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. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | XEME Biopharma Inc. |
Last Updated
April 8, 2021
