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Breast CancerPhase 2NCT01339000

Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy

A Phase 2 study testing Glycosylated Recombinant Human Interleukin-7, Diphtheria/Tetanus Vaccine and Polio Vaccine in people with Breast Cancer and Colon Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Background: Drugs given to treat cancer (chemotherapy) can weaken the human immune system. But it can also become weaker because of aging. Interleukin (IL)-7, a molecule produced naturally in the body, can help improve the function of the immune system. Read more about this study

Who is it for?
Ages 60 to 100 years
Conditions the study is for
Breast Cancer, Colon Cancer, Bladder Cancer
What is being tested?
Glycosylated Recombinant Human Interleukin-7, Diphtheria/Tetanus Vaccine and Polio Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesUnited States
Study dates
Apr 2011to Apr 2016
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 60 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults over the age of 60
  • Documentation of positive diagnosis for any of the following:
  • Non metastatic breast carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant radio / chemotherapy.
  • Stage II or III colon carcinoma following appropriate surgery and adjuvant chemotherapy or following appropriate neoadjuvant chemoradiation/surgery and adjuvant chemotherapy.
  • Stage II bladder carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant chemotherapy. Patients with recurrent tumors are not eligible.
  • Appropriate therapy for each disease must be consistent with the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology available at the web site: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp
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  • Completed cancer specific therapy (including surgery, radiotherapy and/or chemotherapy) a minimum of 4 weeks prior to entry. (Subjects with hormone receptor positive breast carcinoma maintained on hormonal therapy following chemotherapy and radiation are eligible).
  • Completed cancer specific therapy at most 6 months prior to entry.
  • Reasonable expectation that no chemotherapy will be given in the subsequent 6 months (Principal Investigators (PIs) discretion).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the upper limit of normal.
  • Bilirubin < 1.5.
  • Absolute Neutrophil Count greater than l000 / mm(3).
  • Platelet count greater than 75K.
  • International normalized ratio (INR)/partial thromboplastin time (PTT) within 1.5 times upper limit of normal (Common Terminology Criteria in Adverse Events (CTCAE) 4.0 grade 1 abnormality is acceptable)
  • Serum creatinine within 1.5 times upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable)
  • Creatine phosphokinase (CPK) within 2.5 times upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable)
  • Serum albumin greater or equal to 3g/dl (CTCAE 4.0 grade 1 abnormality is acceptable)
  • Serum electrolytes within normal limits (CTCAE 4.0 grade 1 abnormality is acceptable)
  • Karnofsky performance status greater or equal to 70%.

Who cannot join

  • Significant heart disease defined as:
  • Significant coronary arterial disease
  • myocardial infarction in the last 6 months, angina in the previous 3 months,
  • Troponin elevation at level of myocardial infarction as defined by the manufacturer
  • Ischemic changes on electrocardiogram (ECG)
  • Atrio-ventricular block greater than 1st degree, in absence of pacemaker,
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  • Corrected QT interval (QTc) greater than 480ms (CTCAE 4.0 grade 1 abnormality is acceptable),
  • History of ventricular arrhythmia,
  • Left Ventricular Ejection Fraction below the institutional limit of normal,
  • Positive serology for human T-lymphotropic viruses, type 1 (HTLV I), human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection including a positive hepatitis B serology indicative of previous immunization (i.e. hepatitis B surface antibody (HBs Ab) positive and hepatitis B core antibody (HBc Ab) negative)
  • History of autoimmune disease: patients with vitiligo or endocrine disease controlled by replacement therapy including, diabetes, thyroid and adrenal disease may be enrolled
  • Patients requiring chronic immunosuppressive therapy (including corticosteroids) for any medical condition,
  • Splenomegaly or history of proliferative hematologic disease
  • Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
  • Inability or refusal to practice contraception during therapy (as physiologically relevant)
  • History of medical or psychiatric disease which, in the view of the principal investigator, would preclude safe treatment
  • Cognitive impairment
  • Serious bleeding diathesis or those who are on therapeutic anticoagulation
  • Previous exposure to Hepatitis A or B vaccines
  • Patients who received a tetanus and diphtheria (Td) or tetanus, diphtheria- acelluar, pertussis (Tdap) immunization in the previous 5 years,
  • History of anaphylaxis or serious allergic reactions to previous administration of any of the vaccines
  • Known hypersensitivity to any of the following: diphtheria toxoid, neomycin, polymixin B, streptomycin, 2 phenoxyethanol, formaldehyde, aluminum hydroxide, yeast
  • Patients who had received one or more doses of the pneumococcal polysaccharide vaccine 23 (PPSV23) vaccine in the previous 12 months
  • Inability to give informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: A Multicenter Phase II Study of Enhancement of Immune Reconstitution and Vaccine Responses With Administration of Glyco-Recombinant Human IL-7(CYT107) in Older Subjects Following Chemotherapy

Background: Drugs given to treat cancer (chemotherapy) can weaken the human immune system. But it can also become weaker because of aging. Interleukin (IL)-7, a molecule produced naturally in the body, can help improve the function of the immune system. Researchers want to study the effects of IL-7 on immune system function in two different groups of older people. One group will be people who have received vaccines before IL-7. The other group will be people who have received Vaccines after IL-7.

Objectives: To evaluate the effect of IL-7 on the immune system responses to vaccines in older people following chemotherapy.

Read more

Eligibility: People at least 60 years of age who have recently finished chemotherapy for breast, colon, or bladder cancer.

Design:

  • People in the study will be screened with a physical examination, medical history, and blood tests. Other screening tests, such as tumor imaging, may also need to be performed.
  • Everyone will receive a series of five different vaccines commonly used to prevent diseases. We will compare the responses of people in Sequence 1 who will receive vaccines before IL-7 with the responses of people in Sequence 2 who received the same vaccines after IL-7.
  • The vaccines will be given randomly in two Arms at different times.
  • Arm 1: diphtheria and tetanus, polio, pneumonia (with two booster shots), hepatitis B (with two booster shots), and hepatitis A (with one booster shot),
  • Arm 2: hepatitis A (with one booster shot), hepatitis B (with two booster shots), pneumococcal (with two booster shots), diphtheria and tetanus, polio, pneumonia (with two booster shots)
  • There are 5 vaccines to be given to each subject, following one of two randomly assigned sequences of vaccine administration (Sequence 1 or Sequence 2).
  • The first vaccine arm contains the two diphtheria protein containing vaccines tetanus and diphtheria (Td) and pneumococcal conjugate 13 (PCV13) and polio. The second vaccine arm contains the Hepatitis A and Hepatitis B vaccines. Subjects will either get tetanus, diphtheria, polio, and pneumonia vaccines before IL-7 therapy (Sequence 1) or hepatitis A and hepatitis B vaccines before IL-7 therapy (Sequence 2). The response to vaccines will be evaluated 4 weeks after vaccination. This will be followed by IL-7 therapy, then administration of the other group of vaccines. Therefore, subjects on both arms will receive the same set of vaccines, just at different times with respect to IL-7 therapy.
Read the detailed description

BACKGROUND:

  • Interleukin-7 is a homeostatic cytokine with a critical role in lymphoid homeostasis through which it exerts its immune-restorative effects, particularly re-expansion of the naive and memory T cell subsets.
  • The clinical implications of the kinetics, nature and extent of immune reconstitution defects following standard or ablative chemotherapy in older adults with cancer (in particular the lack of reconstitution of large pools naive T cell with broad repertoire diversity and of memory T cells) are not fully appreciated.
  • As chemotherapy often induces only temporary complete or partial disease responses but no cure, candidates for novel immunotherapy strategies may be significantly impeded in their responses to active immunotherapy attempts, the therapeutic potential of which may be misjudged or altogether overlooked.
  • Recombinant human interleukin-7 (rhIL-7) may play a role in immune reconstitution and immune enhancement in various circumstances of immune insufficiency in older individuals following chemotherapy or in the context of enhancing cancer immunotherapy or during immune senescence.

OBJECTIVES:

  • Evaluate and quantify the impact of interleukin-7 (CYT107) therapy on specific immune responses to each vaccine (in particular to neo antigens) in older subjects following chemotherapy.

ELIGIBILITY:

  • Adults over the age of 60.
  • Diagnosis of non metastatic breast, bladder or colorectal cancer following adjuvant / neo-adjuvant chemotherapy.
  • Completed a treatment with chemotherapy a minimum of 4 weeks prior to entry.
  • Reasonable expectation that no chemotherapy will be given in the subsequent 6 months.

DESIGN:

  • Subjects will be enrolled following the specific therapy for their respective diseases.
  • Subjects will undergo immunizations with various antigens, randomized to be administered either before or after treatment with CYT107
  • The vaccines, randomly assigned to be administered before CYT107 therapy are administered four weeks before the start of CYT107 therapy.
  • CYT107 is administered once a week for 3 doses (20 microg/kg/dose) via intramuscular route (IM)
  • The vaccines, randomly assigned to be administered after CYT107 therapy are administered 17 days after the first dose of CYT107 therapy.
Being tested
Glycosylated Recombinant Human Interleukin-7, Diphtheria/Tetanus Vaccine, Polio Vaccine, Pneumococcal Vaccine, Hepatitis A Vaccine
Keywords
Colorectal Cancer, Breast Cancer, Immunization, Immunocompromised Host, Bladder Cancer, Colon Cancer
Medical subject headings
Breast Neoplasms, Colonic Neoplasms, Urinary Bladder Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glycosylated Recombinant Human Interleukin-7Drug

    Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection

  • Diphtheria/Tetanus VaccineBiological

    Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.

  • Polio VaccineBiological

    Polio Vaccine will be administered according to the randomized schedule per protocol.

  • Pneumococcal VaccineBiological

    Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.

  • Hepatitis A VaccineBiological

    Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.

  • Hepatitis B VaccineBiological

    Hepatitis B vaccine will be administered according to the randomization schedule per protocol.

Study groups in NCT01339000
Study groupRoleWhat they receive
Arm A -Sequence 1 ImmunizationsExperimentalReceive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Receives: Drug: Glycosylated Recombinant Human Interleukin-7; Biological: Diphtheria/Tetanus Vaccine; Biological: Polio Vaccine; Biological: Pneumococcal Vaccine; Biological: Hepatitis A Vaccine; Biological: Hepatitis B Vaccine
Arm B - Sequence 2 ImmunizationsExperimentalReceive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Receives: Drug: Glycosylated Recombinant Human Interleukin-7; Biological: Diphtheria/Tetanus Vaccine; Biological: Polio Vaccine; Biological: Pneumococcal Vaccine; Biological: Hepatitis A Vaccine; Biological: Hepatitis B Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on Specific Immune Responses to Vaccines (in Particular to Neo Antigens) in Older Subjects Following Chemotherapy

    Measured: 8 weeks

Secondary outcomes (4)

  1. Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on the T Cell Receptor Diversity in Older Subjects Following Chemotherapy

    Measured: 10 weeks

  2. Evaluate the Effects of Interleukin-7 (CYT107) Therapy on the Quality of T Cell Specific Responses by Multiparameter Flow Cytometry

    Measured: 8 weeks

  3. Based on the First Two Primary Objectives, Consider and Discuss the Need for Larger Studies to Evaluate the Potential Benefit of Interleukin-7 (CYT107) Administration in a Broad, Mass Protection Strategy for an Aging Population

    Measured: 1 year

  4. Number of Participants With Adverse Events

    Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionApr 2016
  4. Study completionApr 2016

Why it stopped: Company supplying drug declared bankruptcy, thus there was no drug supply.

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01339000
Sponsor's protocol ID
110146
Other IDs
11-C-0146
Status last verified
May 2016
First submitted
19 Apr 2011
Last updated
22 Jun 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • BOWMAN BU Jr, PATNODE RA. NEUTRALIZATION OF BACTERIOPHAGE PHI-X174 BY SPECIFIC ANTISERUM. J Immunol. 1964 Apr;92:507-14. No abstract available.

    PubMed 14139020

  • Finkelstein MS, Uhr JW. Antibody formation. V. The avidity of gamma-M and gamma-G guinea pig antibodies to bacteriophage phi-x 174. J Immunol. 1966 Nov;97(5):565-76. No abstract available.

    PubMed 5926449

  • ROLFE U, SINSHEIMER RL. ANTIGENS OF BACTERIOPHAGE PHI-X174. J Immunol. 1965 Jan;94:18-21. No abstract available.

    PubMed 14253517

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glycosylated Recombinant Human Interleukin-7, Diphtheria/Tetanus Vaccine and Polio Vaccine in people with Breast Cancer and Colon Cancer, run by National Cancer Institute (NCI) 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 19 inclusion and 24 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 22 Jun 2016. 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?

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 22 Jun 2016). 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?

Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on Specific Immune Responses to Vaccines (in Particular to Neo Antigens) in Older Subjects Following Chemotherapy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01339000, which also lists 3 linked publications.

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 22 Jun 2016.

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