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

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ClinicalTrials.gov Identifier: NCT02194751
Recruitment Status : Not yet recruiting
First Posted : July 18, 2014
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
XEME Biopharma Inc.

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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Biological: Oncoquest-L vaccine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Vaccines

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.




Primary Outcome Measures :
  1. Overall tumor response rate [ Time Frame: Up to 2 years ]
    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 :
  1. Assessment of complete and partial tumor response rates [ Time Frame: Up to 2 years ]
    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.

  2. Assessment of time until initiation of radiotherapy or systemic therapy [ Time Frame: Up to 2 years ]
  3. 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 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.

  4. 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. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194751


Contacts
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Contact: Karen Rados 770-400-6629 Karon.Rados@ctca-hope.com
Contact: Mittie Mitchell, RN 770-400-7194 Mittie.Mitchell@ctca-hope.com

Locations
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United States, Georgia
Southeastern Regional Medical Center at CTCA
Newnan, Georgia, United States, 30265
Contact: Karen Rados    770-400-6629      
Sponsors and Collaborators
XEME Biopharma Inc.
Investigators
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Principal Investigator: Brion Randolph, MD Southeastern Regional Medical Center at Cancer Treatment Centers of America
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Responsible Party: XEME Biopharma Inc.
ClinicalTrials.gov Identifier: NCT02194751    
Other Study ID Numbers: X13-21008
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin