Ronald Levy, MD
Phase I/II of a CpG-Activated Whole Cell Vaccine Followed by Autologous ?Immunotransplant? for MCL
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study will evaluate the safety and efficacy of treating newly diagnosed mantle cell lymphoma patients with an autologous, tumor-derived vaccine followed by re-infusion of vaccine-primed T cells combined with standard autologous hematopoietic stem cell transplant (AHCT). CpG-MCL vaccine is derived from each patient?s own tumor, treated in vitro with the immunostimulatory CpG-enriched oligodeoxynucleotide - PF-3512676 - and irradiated. The overall treatment schema is that patients receive: induction chemotherapy, preliminary vaccinations, pheresis to harvest vaccine-primed T cells, myeloablative chemotherapy followed by autologous stem cell rescue (AHCT) along with re-infusion of vaccine-primed T-cells (?immunotransplant?) and repeat vaccinations zero and three months post-transplant.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Vaccine: CpG-MCL vaccine, primed T-cells
- Procedure: Autologous peripheral blood stem cell transplantation
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to 70 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Patients must be newly diagnosed with MCL, have an accessible disease site for excisional biopsy or sufficient peripheral blood tumor burden to safely leukapherese.
- By standard clinical criteria be medically appropriate to receive induction chemotherapy and high-dose chemotherapy with AHCT.
- Must be between 18 to 70 years of age.
- Serum creatinine <2.0 or 24-hour creatinine clearance >60 ml/min.
- Patients must be HIV negative.
- ECOG performance status 0, 1, or 2.
- Patients must be capable of signing an informed consent.
Key Exclusion Criteria:
- Patients who are currently taking immunosuppressive medications.
- Severe psychological or medical illness.
- Patients may not be receiving any other investigational agents.
- Pregnant or lactating women.
Additional Study Details
Official Title:
Phase I/II Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous ?Immunotransplant? for Mantle Cell LymphomaAnticipated start date:
8/18/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- NIH
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- To compare tumor specific immune response before and after vaccination and immunotransplant
Secondary Outcomes:
- Evaluate immune responses and quantitative assessment of molecular residual disease
Total Number to be Enrolled:
30Total Number to be Enrolled at Stanford:
30More Information
Secondary ID(s):
- 96940
- LYMNHL0040
- NCT00490529
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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