Phase I/II of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL - Full Text View

Sponsor:	Stanford University
Information provided by (Responsible Party):	Stanford University
ClinicalTrials.gov Identifier:	NCT00490529

Purpose

While autologous hematopoietic stem cell transplant (AHCT) has been shown to cure some subtypes of non-Hodgkin's lymphoma (NHL), mantle cell lymphoma (MCL) still has a prognosis marked by relapse. This study will evaluate the safety and efficacy of treating newly diagnosed MCL 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 along with re-infusion of vaccine-primed T-cells ('immunotransplant') and repeat vaccinations zero and three months post-transplant.

Condition	Intervention	Phase
Lymphoma, Mantle-Cell	Biological: CpG-MCL vaccine, primed T-cells Procedure: Autologous peripheral blood stem cell transplantation Procedure: CT scan Procedure: PET-CT scan Drug: PF-3512676 Drug: Rituximab	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Lymphoma Nuclear Scans

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

relative increase in anti-tumor immune cells measured after immunotransplant as compared to after primary vaccination. [ Time Frame: endpoint is assessed 14-28 days after stem cell transplant. Immune assays are batched and are run within 1 year of obtaining each sample endpoint. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate quantitative assessment of molecular residual disease and progression-free survival relative to a historical control cohort [ Time Frame: 1 year and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2009
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Standard of Care

Other Name: CpG-activated, autologous tumor vaccine

Standard of Care

Other Name: Hematopoietic stem cell transplantation

Standard of Care

Other Name: X-ray computed tomography

Standard of Care

Other Name: Poset emission tomography

18 mg subcutaneous injection

Other Name: Pfizer

375 mg/m2 iv (immediately following "Preliminary Vaccination" with Id-KLH)

Other Names:

Rituxan
MabThera

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490529

Contacts

Contact: Joshua Brody, MD

(650) 725-4968

lorir@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Joshua Brody, MD 650-725-4968 lorir@stanford.edu
Contact: Cancer Clinical Trials Office (650) 498-7061
Principal Investigator: Ronald Levy
Sub-Investigator: Ranjana Hira Advani
Sub-Investigator: Joshua Brody
Sub-Investigator: Sandra Jeane Horning
Sub-Investigator: Robert S Negrin
Sub-Investigator: Wen-Kai Weng
Sub-Investigator: David Miklos

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Ronald Levy

Stanford University

More Information

Publications:

Brody JD, Goldstein MJ, Czerwinski DK, Levy R. Immunotransplantation preferentially expands T-effector cells over T-regulatory cells and cures large lymphoma tumors. Blood. 2009 Jan 1;113(1):85-94. Epub 2008 Sep 23.

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT00490529 History of Changes
Other Study ID Numbers:	LYMNHL0040, 96940, LYMNHL0040-BMT212
Study First Received:	June 20, 2007
Last Updated:	November 10, 2011
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012