Brain and Central Nervous System TumorsPhase 2NCT00621036
Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma
A Phase 2 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine, sargramostim and methotrexate in people with Brain and Central Nervous System Tumors and Lymphoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Lymphoma, Lymphoproliferative Disorder
- What is being tested?
- autologous immunoglobulin idiotype-KLH conjugate vaccine, sargramostim and methotrexate
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2007to 8 Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
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
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma, Lymphoproliferative Disorder, Small Intestine Cancer
- Being tested
- autologous immunoglobulin idiotype-KLH conjugate vaccine, sargramostim, methotrexate, thiotepa, radiation therapy
- Keywords
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Lymphoma, Lymphoproliferative Disorders, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous immunoglobulin idiotype-KLH conjugate vaccineBiological
sargramostimBiological
methotrexateDrug
thiotepaDrug
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| methotrexate IV once every 2 weeks | Experimental | Not described Receives: Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine; Biological: sargramostim; Drug: methotrexate; Drug: thiotepa; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF
Safety and tolerability
Secondary outcomes (4)
Progression-free survival (PFS)
Time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine
Correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival
Kinetics of humoral immune response development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study start19 Oct 2007
- Primary completion8 Dec 2008
- Study completion8 Dec 2008
Why it stopped: MyVax did not meet its primary endpoints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Maher, MD, PhD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621036
- Sponsor's protocol ID
- SCCC-02F07
- Other IDs
- SCCC-102007-035, CDR0000587504
- Status last verified
- Nov 2018
- First submitted
- 21 Feb 2008
- Last updated
- 26 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00621036
- Acronym / sponsor ID
- SCCC-02F07
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma, Lymphoproliferative Disorder, Small Intestine Cancer
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: MyVax did not meet its primary endpoints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 19 Oct 2007 (actual)
- Primary completion
- 8 Dec 2008 (actual)
- Study completion
- 8 Dec 2008 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methotrexate IV once every 2 weeks | Experimental | Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine, Biological: sargramostim, Drug: methotrexate, Drug: thiotepa, Radiation: radiation therapy |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Biological | methotrexate IV once every 2 weeks |
| sargramostim | Biological | methotrexate IV once every 2 weeks |
| methotrexate | Drug | methotrexate IV once every 2 weeks |
| thiotepa | Drug | methotrexate IV once every 2 weeks |
| radiation therapy | Radiation | methotrexate IV once every 2 weeks |
Primary outcome
Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF
Safety and tolerability
4 secondary outcomes
Progression-free survival (PFS)
Time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine
Correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival
Kinetics of humoral immune response development
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Maher, MD, PhD principal investigator
Simmons Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine, sargramostim and methotrexate in people with Brain and Central Nervous System Tumors and Lymphoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.