Lymphoma, Low-GradePhase 2NCT00036426
Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma
A Phase 2 study testing FavId (Id-KLH) active immunotherapy in people with Lymphoma, Low-Grade, run by Favrille at 12 sites in United States.
Trial summary
The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Low-Grade
- What is being tested?
- FavId (Id-KLH) active immunotherapy
- How many people
- 22 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2001to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)
- Patients that have responded with at least stable disease to their most recent chemo- or anti-CD20 antibody (Rituxan®, Zevalin, Bexxar) therapy for a minimum of 90 days and who currently have relapsed or who continue to have stable disease.
- Tumor accessible for biopsy or previously existing biopsy material
- At least 1 additional bidimensional lesion measuring at least 2 cm in each dimension
- Performance status (ECOG) of 0, 1 or 2
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- Absolute Granulocyte count ? 1,000/mm3
- Total Bilirubin < 2 mg/dL
- AST and ALT < 2x Upper Limit of Normal
- Creatinine < 1.5 mg/dL
Who cannot join
- Patients who have had more than 3 prior chemotherapy or anti-CD20 regimens
- Prior fludarabine
- Prior tumor-specific idiotype immunotherapy
- Patients whose disease has progressed within the first 90 days of their last chemotherapy or anti-CD20 treatment
- Concurrent immunosuppressive therapy (high-dose steroids; etc)
- Prior splenectomy
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- Surgery, cancer radiotherapy, steroid therapy, immunotherapy or chemotherapy within 90 days prior to first scheduled vaccination
- Known history of CNS lymphoma or meningeal lymphomatosis
- HIV positive
- Serious non-malignant disease (e.g., psychiatric disorders, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives
- Prior malignancy (excluding nonmelanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for > 2 years
- Treatment with an investigational drug within 30 days prior to study entry
- Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with FavId.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Northwestern University
Chicago, Illinois, 60611
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45219
Henry Ford Hospital
Detroit, Michigan, 48202
University of Florida, Jacksonville
Jacksonville, Florida, 32209
Scripps Stevens Cancer Center
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 92093
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
New York Hospital - Cornell Medical Center
New York, New York, 10021
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oncology Associates of San Diego
San Diego, California, 92123
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
The Bronx, New York, 10466
Medical Group of North County
Vista, California, 92083
About this study
Official title: Phase II Study of FavId (Tumor-Specific Idiotype-KLH) and Soluble GM-CSF Immunotherapy in Patients With Stable or Progressive Grade 1 and 2 Follicular B-Cell Lymphomas
The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor.
Read the detailed description
The purpose of this study was to assess the ability of active immunotherapy to induce tumor regressions in relapsed low-grade lymphoma. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in the production of immunoglobulin idiotype. B-cell lymphomas arise from the clonal expansion of a single B-cell and all tumor cells express that unique Id protein. No normal B-cells possess that Id on their cell surface. Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak immunogens. To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein. Keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein. While initial studies reported a predominately humoral (antibody) response, cellular immunity (T-cells) also plays a critical role in anti-tumor immunity. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation.
- Conditions
- Lymphoma, Low-Grade
- Being tested
- FavId (Id-KLH) active immunotherapy
- Keywords
- lymphoma, vaccine, idiotype, KLH, GM-CSF
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavId (Id-KLH) active immunotherapyBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2002 (estimated)
- Study startMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Low-GradeStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- Favrille
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036426
- Sponsor's protocol ID
- FavId-01
- Status last verified
- Oct 2004
- First submitted
- 9 May 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of FavId (Tumor-Specific Idiotype-KLH) and Soluble GM-CSF Immunotherapy in Patients With Stable or Progressive Grade 1 and 2 Follicular B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00036426
- Acronym / sponsor ID
- FavId-01
- Conditions
- Lymphoma, Low-Grade
- Keywords
- lymphoma, vaccine, idiotype, KLH, GM-CSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants
- Lead sponsor
- FavrilleIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- First posted
- 10 May 2002 (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.
The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor.
Detailed description
The purpose of this study was to assess the ability of active immunotherapy to induce tumor regressions in relapsed low-grade lymphoma. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in the production of immunoglobulin idiotype. B-cell lymphomas arise from the clonal expansion of a single B-cell and all tumor cells express that unique Id protein. No normal B-cells possess that Id on their cell surface. Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak immunogens. To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein. Keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein. While initial studies reported a predominately humoral (antibody) response, cellular immunity (T-cells) also plays a critical role in anti-tumor immunity. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age
- Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)
- Patients that have responded with at least stable disease to their most recent chemo- or anti-CD20 antibody (Rituxan®, Zevalin, Bexxar) therapy for a minimum of 90 days and who currently have relapsed or who continue to have stable disease.
- Tumor accessible for biopsy or previously existing biopsy material
- At least 1 additional bidimensional lesion measuring at least 2 cm in each dimension
Key exclusion criteria (13 listed)
- Patients who have had more than 3 prior chemotherapy or anti-CD20 regimens
- Prior fludarabine
- Prior tumor-specific idiotype immunotherapy
- Patients whose disease has progressed within the first 90 days of their last chemotherapy or anti-CD20 treatment
- Concurrent immunosuppressive therapy (high-dose steroids; etc)
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 |
|---|---|---|
| FavId (Id-KLH) active immunotherapy | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FavId (Id-KLH) active immunotherapy in people with Lymphoma, Low-Grade, run by Favrille at 12 sites 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?
The sponsor lists 10 inclusion and 13 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
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.
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 24 Jun 2005.