LymphomaPhase 2NCT00006478
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma
A Phase 2 study testing autologous tumor cell vaccine, keyhole limpet hemocyanin and sargramostim in people with Lymphoma, run by University of Nebraska at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- autologous tumor cell vaccine, keyhole limpet hemocyanin and sargramostim
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2000to 3 Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 19 years of age
- Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy
- Minimal disease state at day 100 to 6 months post-transplantatio
- Lymph nodes smaller than 2 centimeters (cm)
- Less than 20% bone marrow involvement with lymphoma
- Uncertain complete remission, defined by greater than 75% reduction in the size of the pre-transplantation mass not representing active disease
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- Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy
- o Must have adequate circulating lymphoma cells
- Karnofsky greater than 70%
- Absolute neutrophil count greater than 1,000/mm^3 (No restrictions if study vaccine administered at 6 months after transplantation)
- CD4+ count greater than 200/microliter (No restrictions if study vaccine administered at 6 months after transplantation)
- Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement)
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2 times normal (unless due to lymphomatous involvement)
- Creatinine no greater than 2.0 mg/dL
- Fertile patients must use effective contraception during and for 6 months after study participation
Who cannot join
- Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation
- Not pregnant or nursing/negative pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the humoral and cellular immune responses in patients with follicular non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim (GM-CSF).
- Determine the safety and toxicity of this regimen in these patients in the post-transplant setting.
- Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines.
OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- autologous tumor cell vaccine, keyhole limpet hemocyanin, sargramostim, adjuvant therapy
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous tumor cell vaccineBiological
keyhole limpet hemocyaninBiological
sargramostimBiological
Also called Leukine
adjuvant therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation | Experimental | Phase II trial to study the effectiveness, safety \& toxicity of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.
Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Participants receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose. Receives: Biological: autologous tumor cell vaccine; Biological: keyhole limpet hemocyanin; Biological: sargramostim; Procedure: adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Humoral and Cellular Immune Response
evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation
Measured: immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression
Secondary outcomes (3)
Safety of Idiotype Vaccine
To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Measured: At each immunization and at study completion
Toxicity of Idiotype Vaccine
To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Measured: At each immunization and at study completion
Changes in Quantitative Bcl-2
To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.
Measured: 1 year post transplant evaluation and then annually until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start11 Oct 2000
- Primary completion3 Apr 2008
- Study completion3 Apr 2008
Why it stopped: Genitope suspend drug development by decision made by the FDA March 6, 2008.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie M Vose, MD, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006478
- Sponsor's protocol ID
- 0260-00-FB
- Other IDs
- 37-7109-2007-001, GENITOPE-IND-8294
- Status last verified
- Aug 2023
- First submitted
- 6 Nov 2000
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT00006478
- Acronym / sponsor ID
- 0260-00-FB
- Conditions
- Lymphoma
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Genitope suspend drug development by decision made by the FDA March 6, 2008.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 11 Oct 2000 (actual)
- Primary completion
- 3 Apr 2008 (actual)
- Study completion
- 3 Apr 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 17 Nov 2010
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 cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the humoral and cellular immune responses in patients with follicular non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim (GM-CSF).
- Determine the safety and toxicity of this regimen in these patients in the post-transplant setting.
- Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines.
OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation | Experimental | Biological: autologous tumor cell vaccine, Biological: keyhole limpet hemocyanin, Biological: sargramostim, Procedure: adjuvant therapyPhase II trial to study the effectiveness, safety \& toxicity of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma. Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Participants receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Over 19 years of age
- Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy
- Minimal disease state at day 100 to 6 months post-transplantatio
- Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy
- o Must have adequate circulating lymphoma cells
Key exclusion criteria (2 listed)
- Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation
- Not pregnant or nursing/negative pregnancy test
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 tumor cell vaccine | Biological | Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation |
| keyhole limpet hemocyanin | Biological | Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation |
| sargramostimAlso: Leukine | Biological | Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation |
| adjuvant therapy | Procedure or surgery | Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation |
Primary outcome
Number of Participants With Humoral and Cellular Immune Response
Time frame: immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression
evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation
3 secondary outcomes
Safety of Idiotype Vaccine
Time frame: At each immunization and at study completion
Toxicity of Idiotype Vaccine
Time frame: At each immunization and at study completion
Changes in Quantitative Bcl-2
Time frame: 1 year post transplant evaluation and then annually until disease progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julie M Vose, MD study chair
University of Nebraska
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 tumor cell vaccine, keyhole limpet hemocyanin and sargramostim in people with Lymphoma, run by University of Nebraska 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 15 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 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?
Yes. Results are posted in the registry (first posted 17 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Humoral and Cellular Immune Response (time frame: immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression). 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 18 Sep 2023.