Germ Cell TumorPhase 1NCT00369291
CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
A Phase 1 study testing keyhole limpet hemocyanin and tetanus toxoid in people with Germ Cell Tumor and Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Giving CpG 7909 after an autologous stem cell transplant may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: This phase I trial is studying the side effects and best dose of CpG 7909 in treating patients who have undergone autologous stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Germ Cell Tumor, Leukemia, Lymphoma
- What is being tested?
- keyhole limpet hemocyanin and tetanus toxoid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to May 2010
- Phase
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have undergone autologous transplantation for non-Hodgkin's lymphoma (NHL), Hodgkin's disease, acute myelogenous leukemia (AML), germ cell tumors, or multiple myeloma.
- Patients must be eligible for and consent to participate in study MT1999 06 - Vaccination with tetanus toxoid and Keyhole Limpet Hemocyanin (KLH) to assess antigen specific immune responses (BB-IND 10430).
- Patients will be eligible to receive CpG 7909 and vaccines on or after day 60 post transplant. No patients are eligible for this protocol beyond day 74 post transplant. Therefore, all patients will start therapy on this protocol between days 60-74 post transplant to allow for patient scheduling flexibility.
- Patients must have engraftment and be independent of transfusion support or growth factor support.
- Patients must not have received platelet or red-cell transfusions in the previous week.
- Patients must have been continuously off all growth factors for at least 1 week.
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- Unsupported counts must be:
- platelets ≥ 50,000/ml
- Hgb ≥ 9 gm/ul
- Absolute neutrophil count ≥ 1000/µL
- Absolute lymphocyte count ≥ 500/µL
- Patients must have a current performance status of 0-1 (Eastern Cooperative Oncology Group) or 70-100% (Karnofsky.
- Patients must be afebrile, off antibiotics therapeutic (not prophylactic), and free of evidence of active infection. Patients must be off intravenous (IV) hyperalimentation and IV fluids.
- Minimum laboratory values within 2 weeks of entry: Creatinine ≤ 2.0 mg/dl or CrCl ≥ 50 ml/min, Bilirubin, ALT ≤ 2 x normal
- Age >18 years
- Patients receiving or scheduled to receive planned radiation therapy, growth factor therapy, or steroid therapy during the study period will be ineligible. Patients must have completed all planned post-transplant radiation therapy if applicable.
- Patients must be able to give written informed consent and agree to comply with the study parameters
- Patients must agree to use contraception during the study.
Who cannot join
- Patients with one or more of the following:
- Active infection, or fever >38.2˚C
- Significant nonmalignant disease including documented HIV infection, uncontrolled hypertension (diastolic blood presses >115 mmHg), unstable angina, congestive heart failure (NY Class II), poorly controlled diabetes, coronary angioplasty within 6 months, myocardial infarction with the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmias.
- Hematopoietic growth factors administered within 1 week of study entry.
- Expected to require additional cytotoxic therapy within 30 days of study
- Receiving other post-transplant investigational agents
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- Patients with a history of autoimmune diseases will be ineligible for this protocol
- It is unknown whether CpG 7909 may exacerbate autoimmune disorders by its immunomodulatory effects. Therefore, subjects with a history of autoimmune disease should not receive CpG 7909. Controlled thyroid disease is permissible.
- Systemic corticosteroids or other immunosuppressants
- Pregnant or lactating (It is unlikely and probably unwise that a women of childbearing potential become pregnant this early after transplant, however; if any suspicion, a pregnancy test should be done)
- Not meeting one or more of the eligibility criteria, as listed above
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: CPG 7909 Oligodeoxynucleotides (ODNS) After Autologous Transplantation to Enhance Immune Reconstitution
RATIONALE: Giving CpG 7909 after an autologous stem cell transplant may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of CpG 7909 in treating patients who have undergone autologous stem cell transplant.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether CpG 7909 enhances immune function, as measured by the response to keyhole limpet hemocyanin (neo-antigen) and tetanus toxoid (memory antigen), in patients who have undergone autologous stem cell transplantation.
Secondary
- Determine if dose escalation of CpG 7909, within a range of previously tested safe doses of CpG 7909, impacts upon the primary immune readouts.
OUTLINE: This is a non-randomized, dose-escalation study of CpG 7909.
Patients receive CpG 7909 subcutaneously (SC) on days 1, 7, and 14. Patients receive keyhole limpet hemocyanin SC and tetanus toxoid SC on day 7.
Cohorts of 3-6 patients receive escalating doses of Cp6 7909 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.
Blood is collected at baseline and at approximately day 40 for immunological studies, including immunoenzyme techniques, antibody response assays, and immunophenotyping.
After completion of study treatment, patients are followed every 3 months for 1 year.
- Being tested
- keyhole limpet hemocyanin, tetanus toxoid
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keyhole limpet hemocyaninBiological
Also called KLH
KLH is a foreign protein to humans, it will be used to assess the immune response to a neo-antigen given as a single injection, 1 mg subcutaneously in the arm (per MT1999-06).
tetanus toxoidBiological
Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)
| Study group | Role | What they receive |
|---|---|---|
| CpG 7909 | Experimental | Patients treated with CpG 7909 oligodeoxynucleotides (ODNs) after autologous transplantation to enhance immune reconstitution. Receives: Biological: keyhole limpet hemocyanin; Biological: tetanus toxoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid
anti-KLH IgG
Measured: 1 Month after vaccine
Secondary outcomes (1)
Impact of dose escalation of CpG 7909 on primary immune readouts
Compare primary outcome between cohorts
Measured: At study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2003
- Primary completionMay 2010
- Study completionMay 2010
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 Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcie Tomblyn, MD, MS, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369291
- Sponsor's protocol ID
- 2003LS014
- Other IDs
- UMN-0302M41542, UMN-MT2003-03
- Status last verified
- Nov 2017
- First submitted
- 24 Aug 2006
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPG 7909 Oligodeoxynucleotides (ODNS) After Autologous Transplantation to Enhance Immune Reconstitution
- ClinicalTrials.gov ID
- NCT00369291
- Acronym / sponsor ID
- 2003LS014
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Aug 2006 (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: Giving CpG 7909 after an autologous stem cell transplant may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of CpG 7909 in treating patients who have undergone autologous stem cell transplant.
Detailed description
OBJECTIVES:
Primary
- Determine whether CpG 7909 enhances immune function, as measured by the response to keyhole limpet hemocyanin (neo-antigen) and tetanus toxoid (memory antigen), in patients who have undergone autologous stem cell transplantation.
Secondary
- Determine if dose escalation of CpG 7909, within a range of previously tested safe doses of CpG 7909, impacts upon the primary immune readouts.
OUTLINE: This is a non-randomized, dose-escalation study of CpG 7909.
Patients receive CpG 7909 subcutaneously (SC) on days 1, 7, and 14. Patients receive keyhole limpet hemocyanin SC and tetanus toxoid SC on day 7.
Cohorts of 3-6 patients receive escalating doses of Cp6 7909 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.
Blood is collected at baseline and at approximately day 40 for immunological studies, including immunoenzyme techniques, antibody response assays, and immunophenotyping.
After completion of study treatment, patients are followed every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CpG 7909 | Experimental | Biological: keyhole limpet hemocyanin, Biological: tetanus toxoidPatients treated with CpG 7909 oligodeoxynucleotides (ODNs) after autologous transplantation to enhance immune reconstitution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have undergone autologous transplantation for non-Hodgkin's lymphoma (NHL), Hodgkin's disease, acute myelogenous leukemia (AML), germ cell tumors, or multiple myeloma.
- Patients must be eligible for and consent to participate in study MT1999 06 - Vaccination with tetanus toxoid and Keyhole Limpet Hemocyanin (KLH) to assess antigen specific immune responses (BB-IND 10430).
- Patients will be eligible to receive CpG 7909 and vaccines on or after day 60 post transplant. No patients are eligible for this protocol beyond day 74 post transplant. Therefore, all patients will start therapy on this protocol between days 60-74 post transplant to allow for patient scheduling flexibility.
- Patients must have engraftment and be independent of transfusion support or growth factor support.
- Patients must not have received platelet or red-cell transfusions in the previous week.
Key exclusion criteria (11 listed)
- Active infection, or fever >38.2˚C
- Significant nonmalignant disease including documented HIV infection, uncontrolled hypertension (diastolic blood presses >115 mmHg), unstable angina, congestive heart failure (NY Class II), poorly controlled diabetes, coronary angioplasty within 6 months, myocardial infarction with the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmias.
- Hematopoietic growth factors administered within 1 week of study entry.
- Expected to require additional cytotoxic therapy within 30 days of study
- Receiving other post-transplant investigational agents
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 |
|---|---|---|
| keyhole limpet hemocyaninAlso: KLHKLH is a foreign protein to humans, it will be used to assess the immune response to a neo-antigen given as a single injection, 1 mg subcutaneously in the arm (per MT1999-06). | Biological | CpG 7909 |
| tetanus toxoidTetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06) | Biological | CpG 7909 |
Primary outcome
Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid
Time frame: 1 Month after vaccine
anti-KLH IgG
1 secondary outcome
Impact of dose escalation of CpG 7909 on primary immune readouts
Time frame: At study completion
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 29 Nov 2017.
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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.
Marcie Tomblyn, MD, MS principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing keyhole limpet hemocyanin and tetanus toxoid in people with Germ Cell Tumor and Leukemia, run by Masonic Cancer Center, University of Minnesota 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 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 29 Nov 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Enhanced immune function as measured by response to keyhole limpet hemocyanin and tetanus toxoid (time frame: 1 Month after vaccine). 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 29 Nov 2017.