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Cancer Vaccine

Autologous Tumor Cell-Based Vaccine for Lymphoma

Phase 2
Waitlist Available
Led By Sophie Dessureault, M.D., Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is studying how well giving vaccine therapy together with interleukin-2 after combination chemotherapy works in treating patients with relapsed or de novo stage II, stage III, or stage IV mantle cell lymphoma.

Eligible Conditions
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Immunological Response to Vaccination
Secondary outcome measures
Median Event Free Survival (EFS)
Occurrence of Related Serious Adverse Events (SAEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vaccine and Conventional TherapyExperimental Treatment7 Interventions
Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician. Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP. Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy. Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Vincristine
FDA approved
Dexamethasone
FDA approved
Autologous Tumor Cell-Based Vaccine
2004
Completed Phase 2
~50
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Aldesleukin
FDA approved

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,449 Total Patients Enrolled
23 Trials studying Lymphoma
1,065 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,280 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,357 Patients Enrolled for Lymphoma
Lymphoma Research FoundationOTHER
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Lymphoma
30 Patients Enrolled for Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what purpose is IL-2 most often used as a medication?

"IL-2 is an immunotherapy that can be used to manage pheochromocytomas, eye conditions, and ulcerative colitis."

Answered by AI

Are we enrolling test subjects at this time?

"Presently, this study is not seeking new participants. The clinical trial was originally established on July 1st, 2004 but was most recently updated on August 3rd, 2022. If you are looking for other similar studies, there are 1752 lymphoma trials and 1683 IL-2 trials that are actively enrolling patients."

Answered by AI

Are there other examples in which IL-2 has been studied in a clinical setting?

"As of now, 1683 clinical trials for IL-2 are underway. Out of those, 367 have already progressed to Phase 3 testing. The majority of these studies are based in Madison, Wisconsin, but there are 55671 total locations running trials for IL-2."

Answered by AI

How many individuals are signing up for this research project?

"Unfortunately, this clinical trial is no longer looking for participants. The trial was posted on July 1st, 2004 and updated for the last time on August 3rd, 2022. However, there are presently 1752 studies actively searching for patients with lymphoma and 1683 studies for IL-2 actively enrolling patients."

Answered by AI

What is the groundbreaking nature of this clinical trial?

"IL-2 has been the focus of 1683 studies since 1997, with the first being sponsored by Alfacell. That study completed Phase 3 drug approval in 1997 with 300 patients. In the years since, 2860 more trials have been conducted across 3147 cities and 82 countries."

Answered by AI

What are the odds of somebody having an adverse reaction to IL-2?

"IL-2 safety is estimated to be a 2. While there is some evidence backing its safety, there is no data to support efficacy claims."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
2004. "Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00101101.
~2 spots leftby Apr 2025
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