Clinical trial · Interventional
Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company supplying drug declared bankruptcy, thus there was no drug supply.
Summary
Brief summary (as posted)
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. 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diphtheria/Tetanus Vaccine | Biological | — | UNRESOLVED |
| Glycosylated Recombinant Human Interleukin-7 | Drug | — | UNRESOLVED |
| Hepatitis A Vaccine | Biological | — | UNRESOLVED |
| Hepatitis B Vaccine | Biological | — | UNRESOLVED |
| Pneumococcal Vaccine | Biological | — | UNRESOLVED |
| Polio Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A -Sequence 1 Immunizations
- description
- Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
- interventionNames
- Drug: Glycosylated Recombinant Human Interleukin-7
- Biological: Diphtheria/Tetanus Vaccine
- Biological: Polio Vaccine
- Biological: Pneumococcal Vaccine
- Biological: Hepatitis A Vaccine
- Biological: Hepatitis B Vaccine
- type
- EXPERIMENTAL
- label
- Arm B - Sequence 2 Immunizations
- description
- Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
- interventionNames
- Drug: Glycosylated Recombinant Human Interleukin-7
- Biological: Diphtheria/Tetanus Vaccine
- Biological: Polio Vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 100 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * 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 * 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%. EXCLUSION CRITERIA FOR ALL PARTICIPANTS: * 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, * 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
References
Publications (3)
- BACKGROUNDBOWMAN BU Jr, PATNODE RA. NEUTRALIZATION OF BACTERIOPHAGE PHI-X174 BY SPECIFIC ANTISERUM. J Immunol. 1964 Apr;92:507-14. No abstract available. PMID 14139020
- BACKGROUNDFinkelstein 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. PMID 5926449
- BACKGROUNDROLFE U, SINSHEIMER RL. ANTIGENS OF BACTERIOPHAGE PHI-X174. J Immunol. 1965 Jan;94:18-21. No abstract available. PMID 14253517