LeukemiaEarly Phase 1NCT00020670
Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
A Early Phase 1 study testing CD 40 in people with Leukemia, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The prognosis for children and adults with acute lymphoblastic leukemia (ALL) has improved significantly over the years. Nevertheless, patients who experience disease relapse or induction failure along with patients having unfavorable genetics [t(4;11) or t(9;22)] have dismal prognosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- CD 40
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2001to 1 Jul 2003
- Phase
- Early Phase 1
- 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
- B-cell acute lymphoblastic leukemia
- Disease involving at least 30% of bone marrow or circulating blasts
- In first relapse with at least 1 of the following high-risk features:
- Age under 1 year at diagnosis
- Age over 18 years at diagnosis
- t(9;22)
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- Occurrence of first relapse less than 18 months after diagnosis
- In second relapse or beyond
- Refractory disease
- Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine
- Less than 1 year since tumor cell collection
- Patients in first relapse or beyond must be ineligible for or have declined allogeneic bone marrow transplantation in order to receive study vaccine
- Patients need not be in complete remission to receive study vaccine
- Patients may have received an allogeneic hematopoetic stem cell transplant in the past
- No chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment or within 3 weeks of vaccination
- Adequate hepatic function as defined by: Bilirubin < 2x normal; AST < 3x normal; ALT < 6x normal
- Adequate renal function defined by: Creatinine < 2x normal
- <1 year since tumor cell collection
Who cannot join
- Concurrent treatment as part of another therapeutic research protocol
- Pregnancy or nursing mothers
- Clinically significant pulmonary or cardiac disease
- Clinically significant autoimmune disease
- Documented infection that is active and/or not responding to therapy
- Evidence of HIV infection or known positive HIV serology
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- Lansky performance scale (if <18yo) <60%, Karnofsky performance scale (if >18yo) >60%
- Once vaccination course has started: patients may not receive chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment, hematopoetic growth factors. However between tumor cell collection and vaccine administration, patients may receive non-protocol chemotherapy.
- NOTE
- It is anticipated that there will be a number of patients at first relapse who are eligible for tumor cell collection and vaccine preparation but who are not eligible to receive the vaccination course. These patients will be evaluable for Objective 3.1.1 (feasibility of vaccine preparation). Patients at first relapse who are eligible for vaccine preparation but not administration should instead be treated with standard salvage regimens which may include allogeneic bone marrow transplantation according to the judgement of their primary oncologist. However, these patients represent a population at extremely high risk for progression of their disease following salvage therapy. Many of these patients will therefore be likely to fulfill eligibility criteria for vaccination in the future (i.e.
- should they relapse again, or fail to enter 2nd complete remission). The majority of those patients who relapse for a second time will do so within 1 year. Those patients who become eligible for vaccination because of 2nd relapse within 1 year of tumor cell collection will receive the original vaccine and will not have further vaccine made from tumor cells collected at the time of 2nd relapse. Given the proliferative thrust of the disease in many patients, it will be advantageous to have vaccines already prepared for these patients to reduce the amount of time from 2nd relapse to vaccination.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells
The prognosis for children and adults with acute lymphoblastic leukemia (ALL) has improved significantly over the years. Nevertheless, patients who experience disease relapse or induction failure along with patients having unfavorable genetics [t(4;11) or t(9;22)] have dismal prognosis. For these patients, novel therapeutic approaches such as immunotherapy are needed. In this clinical trial, investigators evaluate whether it is feasible to make a vaccine from leukemia cells and whether this vaccine enables direct immunity against cancer cells in patients.
Read the detailed description
OBJECTIVES Primary
- To determine feasibility of generating a cellular vaccine composed of CD40-activated autologous ALL cells
- To determine feasibility of vaccine administration according to the proposed schedule
- To determine toxicity of vaccination with CD40-activated autologous ALL cells
Secondary
- To assess ALL-specific immunity following vaccination
- To assess the generation of immunity to control antigens
- To develop preliminary information on effect vaccination on tumor response
- Conditions
- Leukemia
- Being tested
- CD 40
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, B-cell adult acute lymphoblastic leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD 40Biological
Also called Autologous tumor cell vaccine
| Study group | Role | What they receive |
|---|---|---|
| CD40 Cell Vaccination | Experimental | Patients will undergo tumor cell collection followed by vaccine preparation and then vaccination. Autologous acute lymphoblastic leukemia (ALL) cells are harvested, cultured with CD40 ligand, pulsed with keyhole limpet hemocyanin (KLH), and then irradiated to produce the vaccine. Patients receive either 1 x 10^7 or 1 x 10^8 CD40 cells/vaccination depending on the number of tumor cells obtained. Vaccinations are administered every two weeks as outpatient therapy. Evaluable patients receive the course of at least 4 vaccinations at weeks 0, 2, 4, 6. Patients may continue receiving vaccinations every 2 weeks if chemotherapy is not required for symptomatic disease. Receives: Biological: CD 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate Of Successful Vaccine Preparation
Vaccine preparation is a success if an adequate number of CD40 activated cells (at least 1 x 10^8 cells) can be generated.
Measured: 6 weeks
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 start20 Feb 2001
- Primary completion1 Apr 2003
- Study completion1 Jul 2003
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Nicholas Haining, MD, Dana-Farber Cancer Institute
- Investigators
- W. Nicholas Haining, BM, BCh, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020670
- Sponsor's protocol ID
- 00-053
- Other IDs
- P01CA068484, P30CA006516, DFCI-00053, NCI-H01-0074
- Status last verified
- Jun 2017
- First submitted
- 11 Jul 2001
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells
- ClinicalTrials.gov ID
- NCT00020670
- Acronym / sponsor ID
- 00-053
- Conditions
- Leukemia
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, B-cell adult acute lymphoblastic leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Feb 2001 (actual)
- Primary completion
- 1 Apr 2003 (actual)
- Study completion
- 1 Jul 2003 (actual)
- First posted
- 27 Jan 2003 (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 prognosis for children and adults with acute lymphoblastic leukemia (ALL) has improved significantly over the years. Nevertheless, patients who experience disease relapse or induction failure along with patients having unfavorable genetics [t(4;11) or t(9;22)] have dismal prognosis. For these patients, novel therapeutic approaches such as immunotherapy are needed. In this clinical trial, investigators evaluate whether it is feasible to make a vaccine from leukemia cells and whether this vaccine enables direct immunity against cancer cells in patients.
Detailed description
OBJECTIVES Primary
- To determine feasibility of generating a cellular vaccine composed of CD40-activated autologous ALL cells
- To determine feasibility of vaccine administration according to the proposed schedule
- To determine toxicity of vaccination with CD40-activated autologous ALL cells
Secondary
- To assess ALL-specific immunity following vaccination
- To assess the generation of immunity to control antigens
- To develop preliminary information on effect vaccination on tumor response
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD40 Cell Vaccination | Experimental | Biological: CD 40Patients will undergo tumor cell collection followed by vaccine preparation and then vaccination. Autologous acute lymphoblastic leukemia (ALL) cells are harvested, cultured with CD40 ligand, pulsed with keyhole limpet hemocyanin (KLH), and then irradiated to produce the vaccine. Patients receive either 1 x 10^7 or 1 x 10^8 CD40 cells/vaccination depending on the number of tumor cells obtained. Vaccinations are administered every two weeks as outpatient therapy. Evaluable patients receive the course of at least 4 vaccinations at weeks 0, 2, 4, 6. Patients may continue receiving vaccinations every 2 weeks if chemotherapy is not required for symptomatic disease. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- B-cell acute lymphoblastic leukemia
- Disease involving at least 30% of bone marrow or circulating blasts
- In first relapse with at least 1 of the following high-risk features:
- Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine
- Less than 1 year since tumor cell collection
Key exclusion criteria (11 listed)
- Concurrent treatment as part of another therapeutic research protocol
- Pregnancy or nursing mothers
- Clinically significant pulmonary or cardiac disease
- Clinically significant autoimmune disease
- Documented infection that is active and/or not responding to therapy
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 |
|---|---|---|
| CD 40Also: Autologous tumor cell vaccine | Biological | CD40 Cell Vaccination |
Primary outcome
Rate Of Successful Vaccine Preparation
Time frame: 6 weeks
Vaccine preparation is a success if an adequate number of CD40 activated cells (at least 1 x 10^8 cells) can be generated.
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: No
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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.
W. Nicholas Haining, BM, BCh study chair
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD 40 in people with Leukemia, run by Dana-Farber Cancer Institute at 2 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 18 inclusion and 11 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 stopped early (reason given: Slow accrual). 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.
What does the primary outcome measure?
Rate Of Successful Vaccine Preparation (time frame: 6 weeks). 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 20 Jun 2017.