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Cancer Vaccine
Vaccine Therapy for Lymphoma
Phase 1
Waitlist Available
Led By Sheeba Thomas
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tissue diagnosis of lymphoplasmacytic lymphoma with surface immunoglobulin G (IgG), immunoglobulin A (IgA) or immunoglobulin M (IgM) phenotype with a monoclonal heavy and light chain as determined by flow cytometry; all primary diagnostic lymph node and/or bone marrow biopsies will be reviewed at the University of Texas M.D. Anderson Cancer Center (UTMDACC)
Patients must provide a lymph node sample of at least 1.5 cm in the long axis, or a bone marrow aspiration sample providing at least 5 million cluster of differentiation (CD)20 and/or CD38+ (approximately 10 ml)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks
Awards & highlights
Study Summary
This trial is testing a cancer vaccine to see if it is safe and effective. The vaccine is made from a person's cancer cells.
Who is the study for?
This trial is for patients with lymphoplasmacytic lymphoma who haven't been treated before. They need a specific type of tumor sample, normal liver function tests, and no severe heart or autoimmune diseases. Participants must be able to consent and follow up, have good physical functioning, and use birth control if necessary.Check my eligibility
What is being tested?
The study is testing a vaccine made from the patient's own cancer cells to see if it can trigger the body's immune system to fight the cancer. It also involves checking biomarkers in the lab to understand how well the vaccine works.See study design
What are the potential side effects?
As this is an early-phase trial focusing on dosage and safety, potential side effects are being studied but may include typical vaccine reactions like soreness at injection site, fever, fatigue or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma diagnosis was confirmed with specific tests for IgG, IgA, or IgM.
Select...
I can provide a large enough lymph node sample or a bone marrow sample with enough CD20 or CD38+ cells.
Select...
I have lymphoplasmacytic lymphoma and haven't been treated yet.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0
Secondary outcome measures
Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (vaccine therapy)Experimental Treatment2 Interventions
Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,480 Total Patients Enrolled
6 Trials studying Lymphoplasmacytic Lymphoma
634 Patients Enrolled for Lymphoplasmacytic Lymphoma
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,207 Total Patients Enrolled
Sheeba ThomasPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
113 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My total bilirubin level is 1.5 mg/dl or lower, unless due to Gilbert's disease.My lymphoma diagnosis was confirmed with specific tests for IgG, IgA, or IgM.I have positive ANA or anti-dsDNA antibodies.I am a woman who is either post-menopausal, surgically sterilized, or will use birth control during and 30 days after the study.I can provide a large enough lymph node sample or a bone marrow sample with enough CD20 or CD38+ cells.Your AST and ALT levels in the blood are not more than two times the upper limit of normal.You have HIV, hepatitis B, or hepatitis C infection.I agree to use contraception throughout the study.I haven't had cancer in the last 5 years, except for certain skin cancers or in-situ cancers that were cured.My heart condition severely limits my daily activities.I have lymphoplasmacytic lymphoma and haven't been treated yet.My kidney function is within the required range.I am fully active or restricted in physically strenuous activity but can do light work.You have had autoimmune diseases, except for Hashimoto's thyroiditis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (vaccine therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given approval to utilizing Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccines?
"Our team at Power rated Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine a 1 due to the limited amount of evidence that currently exists in terms of safety and efficacy."
Answered by AI
Are applicants accepted to participate in this investigation at present?
"According to clinicaltrials.gov, the trial posted on February 26th 2015 is not currently recruiting patients; however, there are 1747 other studies currently open and accepting participants."
Answered by AI
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