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Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma

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ClinicalTrials.gov Identifier: NCT00621036
Recruitment Status : Withdrawn (MyVax did not meet its primary endpoints)
First Posted : February 22, 2008
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

RATIONALE: Vaccines made from a person's cancer proteins may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may make a stronger immune response and kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy together with GM-CSF works in treating patients with CNS lymphoma.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Lymphoma Lymphoproliferative Disorder Small Intestine Cancer Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: sargramostim Drug: methotrexate Drug: thiotepa Radiation: radiation therapy Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • To determine the proportion of patients with CNS lymphoma who develop anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) humoral immune responses in the serum and/or CSF following patient-specific immunotherapy comprising recombinant tumor-derived immunoglobulin Id-KLH conjugate vaccine and sargramostim (GM-CSF).
  • To assess the safety and tolerability of this regimen in these patients.

Secondary

  • To evaluate the progression-free survival (PFS) of patients treated with this regimen.
  • To determine the time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine.
  • To assess the correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival.

Tertiary

  • To evaluate the kinetics of humoral immune response development in patients treated with this regimen.

OUTLINE:

  • Pre-immunotherapy: Patients submit a tumor sample for manufacturing of the idiotype (Id)-keyhole limpet hemocyanin (KLH) conjugate vaccine and undergo placement of an Ommaya reservoir. Patients then receive induction therapy comprising methotrexate IV once every 2 weeks until a maximum radiographic response is achieved, as assessed by MRI of the brain. Patients then receive methotrexate IV once a month for 6 months. Patients with leptomeningeal or CSF involvement also receive intraventricular thiotepa twice a week until the CSF is clear on three evaluations and then once a week until the CSF is clear on four evaluations. Patients under 55 years of age also undergo whole brain radiotherapy (or craniospinal radiotherapy when extensive leptomeningeal disease is present). Patients who achieve a stable response to induction therapy proceed to immunotherapy.
  • Immunotherapy: Patients receive recombinant tumor-derived immunoglobulin Id-KLH conjugate vaccine subcutaneously (SC) on day 1 of weeks 0, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76. Patients also receive sargramostim (GM-CSF) SC on days 1-4 of the same weeks as the Id-KLH conjugate vaccine.

After completion of therapy, patients are followed periodically for up to 2 years.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With CNS Lymphoma
Actual Study Start Date : October 19, 2007
Actual Primary Completion Date : December 8, 2008
Actual Study Completion Date : December 8, 2008


Arm Intervention/treatment
Experimental: methotrexate IV once every 2 weeks Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
Biological: sargramostim
Drug: methotrexate
Drug: thiotepa
Radiation: radiation therapy



Primary Outcome Measures :
  1. Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF
  2. Safety and tolerability

Secondary Outcome Measures :
  1. Progression-free survival (PFS)
  2. Time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine
  3. Correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival
  4. Kinetics of humoral immune response development


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or CSF cytologically confirmed CNS lymphoma with any of the following clinical histories:

    • Primary CNS lymphoma at initial diagnosis
    • Primary CNS lymphoma at relapse
    • Systemic lymphoma with CNS disease at initial diagnosis or at relapse
  • Adequate fresh tissue or cell pellet available for analysis by Genitope Corporation to determine adequacy for idiotype (Id) manufacturing
  • Tumor must express both functional light and heavy chain genes
  • No tumors known or found to be surface immunoglobulin negative
  • Not in leukemic phase (i.e., > 5,000/mm³ circulating tumor cells)

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%
  • WBC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease)
  • Creatinine ≤ 1.5 times ULN
  • Able to undergo placement of an Ommaya reservoir
  • Able to receive induction therapy (chemotherapy with or without brain radiotherapy) with intent to induce remission
  • Speaks English or Spanish
  • No other malignancy within the past 3 years, except adequately treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ
  • Not pregnant or nursing
  • No immunosuppressive viral infections as evidenced by HIV antibody or antigen, hepatitis B antigen, or hepatitis C antibody or antigen positivity
  • No history of autoimmune disease that required treatment within the past 5 years, including previously treated autoimmune hemolytic anemia or immune thrombocytopenia

PRIOR CONCURRENT THERAPY:

  • More than 30 days since prior and no concurrent participation in another therapeutic clinical trial
  • More than 2 weeks since prior steroids
  • No concurrent immunosuppressives, including corticosteroids

    • Transient use of optical or nasal steroid solutions is allowed
  • No other concurrent anticancer therapy or therapy for non-Hodgkin lymphoma

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): NCT00621036


Locations
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United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Elizabeth Maher, MD, PhD Simmons Cancer Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00621036     History of Changes
Other Study ID Numbers: SCCC-02F07
SCCC-102007-035
CDR0000587504 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

Keywords provided by University of Texas Southwestern Medical Center:
primary central nervous system non-Hodgkin lymphoma
primary central nervous system Hodgkin lymphoma
stage IV adult T-cell leukemia/lymphoma
adult nasal type extranodal NK/T-cell lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage IV mycosis fungoides/Sezary syndrome
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
intraocular lymphoma
post-transplant lymphoproliferative disorder
cutaneous B-cell non-Hodgkin lymphoma
Waldenström macroglobulinemia
small intestine lymphoma

Additional relevant MeSH terms:
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Folic Acid Antagonists
Lymphoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Lymphoproliferative Disorders
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Vaccines
Methotrexate
Immunoglobulins
Antibodies
Sargramostim
Thiotepa
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents