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Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma

This study is currently recruiting participants.
Verified August 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01209871
First Posted: September 27, 2010
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
The goal of this clinical research study is to find the highest tolerable dose of a cancer vaccine that can be given to patients with asymptomatic lymphoplasmacytic lymphoma (LPL). The safety of this vaccine is also being studied.

Condition Intervention Phase
Lymphoma Lymphoplasmacytic Lymphoma Waldenström Macroglobulinemia Biological: DNA Vaccine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of a Novel Lymphoma DNA Vaccine Encoding a MIP3a-Fused Lymphoma Idiotype [ Time Frame: 4 weeks ]
    MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose-limiting toxicity (DLT).


Secondary Outcome Measures:
  • Immune Response [ Time Frame: 12 weeks ]
    Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells in the post-vaccine PBMC sample at 12 weeks as compared to the pre-vaccine sample, with a minimum precursor frequency of 1 in 80,000 cells if the precursor frequency in the pre-vaccine sample is zero. Rate of immune response estimated.


Estimated Enrollment: 12
Actual Study Start Date: February 26, 2015
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 - DNA Vaccine

Series of 3 autologous lymphoma immunoglobulin derived scFV-chemokine DNA vaccinations.

Cohort 1 dose 500 μg intramuscularly at 4-week intervals (+/- 3 business days) according to the following schedule: 0, 4, and 8 weeks.

Biological: DNA Vaccine
Series of 3 autologous lymphoma immunoglobulin derived scFV-chemokine DNA vaccinations (Cohort 1 dose 500 μg; Cohort 2 dose 2500 μg) intramuscularly at 4-week intervals (+/- 3 business days) according to the following schedule: 0, 4, and 8 weeks.
Other Names:
  • plasmid DNA
  • lymphoma DNA vaccine
  • lymphoma immunoglobulin derived scFV-chemokine DNA vaccinations
Experimental: Cohort 2 - DNA Vaccine

Series of 3 autologous lymphoma immunoglobulin derived scFV-chemokine DNA vaccinations.

Cohort 2 dose 2500 μg intramuscularly at 4-week intervals (+/- 3 business days) according to the following schedule: 0, 4, and 8 weeks.

Biological: DNA Vaccine
Series of 3 autologous lymphoma immunoglobulin derived scFV-chemokine DNA vaccinations (Cohort 1 dose 500 μg; Cohort 2 dose 2500 μg) intramuscularly at 4-week intervals (+/- 3 business days) according to the following schedule: 0, 4, and 8 weeks.
Other Names:
  • plasmid DNA
  • lymphoma DNA vaccine
  • lymphoma immunoglobulin derived scFV-chemokine DNA vaccinations

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Age >/= 18 years
  2. Tissue diagnosis of Lymphoplasmacytic Lymphoma with surface IgG, IgA or 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)
  3. Previously untreated patients with lymphoplasmacytic lymphoma (of any subtype: IgG, IgA, IgM) in the asymptomatic phase
  4. Patients must provide a lymph node sample of at least 1.5cm in the long axis, or a bone marrow aspiration sample providing at least 5 million CD20 and/or CD38+ (approximately 10 ml)
  5. ECOG performance status of 0 or 1
  6. Serum creatinine </= 1.5 mg/dl and a Creatinine clearance >/= 30 ml/min.
  7. Total Bilirubin </= 1.5 mg/dl unless felt secondary to Gilbert's disease and AST/ALT </= 2 x upper limit of normal
  8. Ability to provide informed consent, and to return to clinic for adequate follow-up for the period that the protocol requires
  9. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 30 days after the last vaccination has been administered.
  10. Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

  1. HIV, Hepatitis B and/or Hepatitis C infection
  2. Pregnancy or lactating females
  3. Patients with previous history of malignancy within the last 5 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in-situ of other organs
  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. Patients with New York Heart Association Class 3 or 4 disease
  6. Patients with a history of autoimmune diseases except for Hashimoto's thyroiditis
  7. Patients with positive ANA and/or anti-dsDNA antibodies
  Contacts and Locations
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): NCT01209871


Contacts
Contact: Sheeba K. Thomas, MD 713-792-2860

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sheeba K. Thomas, MD    713-792-2860      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Sheeba K. Thomas, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01209871     History of Changes
Other Study ID Numbers: 2009-0465
NCI-2012-01897 ( Registry Identifier: NCI CTRP )
First Submitted: September 24, 2010
First Posted: September 27, 2010
Last Update Posted: August 24, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Lymphoplasmacytic Lymphoma
Recombinant DNA
Fusion DNA Vaccine
Waldenström macroglobulinemia

Additional relevant MeSH terms:
Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Vaccines
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs