Lymphoma, FollicularPhase 2NCT00081809
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
A Phase 2 study testing autologous human tumor-derived HSPPC-96 in people with Lymphoma, Follicular and Lymphoma, Small Lymphocytic, run by Agenus Inc. at 1 site in United States.
Trial summary
Primary Objectives: To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are: the rate of complete and partial responses the time to progression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Follicular, Lymphoma, Small Lymphocytic
- What is being tested?
- autologous human tumor-derived HSPPC-96
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Jun 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom's macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease;
- Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96;
- Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor;
- A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation;
- Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue;
- Life expectancy of at least 16 weeks;
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- Zubrod performance status of less then or equal to 2;
- Adequate bone marrow function;
- Adequate hepatic function;
- Adequate renal function;
- Signed written informed consent;
- Patients of child-bearing potential must practice contraception, which is adequate in the opinion of the Principal Investigator;
- Patients of child-bearing potential must have a negative serum pregnancy test prior to entry into the study and must not be lactating;
- Patients must be willing to be followed at the M. D. Anderson Cancer Center during the course of treatment and follow-up;
- Electrocardiogram if none performed in the prior six months;
- Patients must have no chemotherapy, immunotherapy, radiotherapy, or experimental anti-cancer therapy within six weeks prior to starting autologous HSPPC-96 administration;
- Patients must have fully recovered from prior anti-cancer therapy;
- Tumor measurements and staging no more than 4 weeks prior to receiving the first dose of autologous HSPPC-96.
Who cannot join
- Patients with active or prior history of central nervous system lymphoma;
- Patients with serious intercurrent medical illnesses, requiring hospitalization;
- Patients with a history of primary or secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on functional immune system) or patients taking immunosuppressive drugs such as systemic corticosteroids;
- Women who are pregnant or lactating;
- Patients participating in another clinical trial;
- Patients receiving growth factors of any kind, including G-CSF, GM-CSF, or Epogen;
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- Patients with bulky disease, defined as greater than 10 cm in diameter;
- Patients with positive HIV antibody;
- Patients with more than 4 previous treatment regimens will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)
Primary Objectives:
- To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are:
- the rate of complete and partial responses
- the time to progression.
Read more
Secondary Objectives:
- To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks.
- To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.
- To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient.
- To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.
- Conditions
- Lymphoma, Follicular, Lymphoma, Small Lymphocytic
- Being tested
- autologous human tumor-derived HSPPC-96
- Keywords
- non-Hodgkin's lymphoma, Brill-Symmers Disease, Follicular Lymphoma, Lymphoma, Giant Follicular, Lymphoma, Nodular, Follicular Lymphoma, Giant, Giant Follicular Lymphoma, Lymphocytic Lymphoma, Diffuse, Well-Differentiated, Lymphocytic Lymphoma, Well-Differentiated, Lymphoma, Lymphocytic, Diffuse, Well-Differentiated, Lymphoma, Lymphocytic, Well-Differentiated, Lymphoma, Lymphoplasmacytoid, CLL, Lymphoma, Small Lymphocytic, Plasmacytoid, Lymphoplasmacytoid Lymphoma, CLL, Diffuse Well-Differentiated Lymphocytic Lymphoma, Lymphocytic Lymphoma, Diffuse, Well Differentiated, Lymphocytic Lymphoma, Well Differentiated, Lymphoma, Lymphocytic, Diffuse, Well Differentiated, Lymphoma, Lymphocytic, Well Differentiated, Lymphoma, Mucosa-Associated Lymphoid Tissue
- Medical subject headings
- Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous human tumor-derived HSPPC-96Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2004 (estimated)
- Study startMar 2000
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies 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
- 35 participants
Sponsor and investigators
- Lead sponsor
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081809
- Sponsor's protocol ID
- C-100-09
- Other IDs
- MDACC Protocol ID99-354
- Status last verified
- Sep 2023
- First submitted
- 20 Apr 2004
- Last updated
- 28 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)
- ClinicalTrials.gov ID
- NCT00081809
- Acronym / sponsor ID
- C-100-09
- Conditions
- Lymphoma, Follicular, Lymphoma, Small Lymphocytic
- Keywords
- non-Hodgkin's lymphoma, Brill-Symmers Disease, Follicular Lymphoma, Lymphoma, Giant Follicular, Lymphoma, Nodular, Follicular Lymphoma, Giant, Giant Follicular Lymphoma, Lymphocytic Lymphoma, Diffuse, Well-Differentiated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 23 Apr 2004 (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.
Primary Objectives:
- To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are:
- the rate of complete and partial responses
- the time to progression.
Secondary Objectives:
- To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks.
- To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.
- To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient.
- To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom's macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease;
- Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96;
- Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor;
- A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation;
- Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue;
Key exclusion criteria (9 listed)
- Patients with active or prior history of central nervous system lymphoma;
- Patients with serious intercurrent medical illnesses, requiring hospitalization;
- Patients with a history of primary or secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on functional immune system) or patients taking immunosuppressive drugs such as systemic corticosteroids;
- Women who are pregnant or lactating;
- Patients participating in another clinical trial;
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 human tumor-derived HSPPC-96 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
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 human tumor-derived HSPPC-96 in people with Lymphoma, Follicular and Lymphoma, Small Lymphocytic, run by Agenus Inc. 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?
The sponsor lists 18 inclusion and 9 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: finished, as of the sponsor's last update on 28 Sep 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 28 Sep 2023.