Neoplasms by SitePhase 2NCT03003195
The P10s-PADRE Basket Trial: Vaccination of Metastatic Cancer Patients
A Phase 2 study testing P10s-PADRE in people with Neoplasms by Site and Metastatic Cancer, run by University of Arkansas.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms by Site, Metastatic Cancer
- What is being tested?
- P10s-PADRE
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Mar 2021
- Phase
- Phase 2
- 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
- Subjects of all races with clinical Stage IV cancer of any type, staged according to American Joint Commission on Cancer (AJCC), sixth edition, receiving any line of standard treatment for the specific cancer and with stable disease or better for at least two months will be invited to participate.
- Subjects of all races with clinical Stage IV cancer of any type, staged according to American Joint Commission on Cancer (AJCC), sixth edition, who have no standard treatment options for the specific cancer (Patients whose standard of care consists of watchful waiting) and who fulfill the other eligibility criteria will be invited to participate.
- Measurable or evaluable disease.
- Patients with bone-only disease will be allowed to participate.
- Ages 18 years and older.
- ECOG Performance status 0, 1 or 2.
Show all 12Show fewer
- White blood cells (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration
- Platelet count ≥ 100,000/mm3 prior to registration
- Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration or Aspartate aminotransferase test (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration
- Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration.
- Serum creatinine ≤ 1.8 mg/dl obtained within 3 weeks prior to registration.
- Must sign an informed consent document approved by UAMS Institutional Review Board (IRB).
Who cannot join
- Active infection requiring treatment with antibiotics.
- Existing diagnosis or history of organic brain syndrome that precludes participation in the full protocol.
- Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol.
- Other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ, or basal or squamous skin cancer are eligible, provided they are disease-free of these other malignancies at the time of registration. Subjects with other malignancies - other than the one for which they are being treated - are eligible if they have been continuously disease free (from the old cancer) for ≥ 5 years prior to the time of registration.
- Existing diagnosis or history of autoimmune disorders or conditions of immunosuppression. This includes, but is not limited to, being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in standard therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who have been on systemic steroids will require a 6-week washout period. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.
- Pregnancy or breast feeding, due to the unknown effects of peptide/mimotope vaccines on a fetus or infant. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study drug, and must be counseled to use an accepted and effective method of contraception while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods include oral contraceptives, barrier method, IUDs, and abstinence.
- Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment.
- Patients receiving checkpoint inhibitors.
About this study
Official title: A Combined Phase I/II Study of a Carbohydrate Mimotope-Based Vaccine with MONTANIDE™ ISA 51 VG STERILE for Metastatic Cancer
The purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer.
Read the detailed description
After signing Institutional Review Board (IRB) approved consent, subjects with metastatic cancer will be enrolled. The vaccine doses will be prepared and dispensed by the University of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions. Subjects will receive 1.0 mL subcutaneous injections of the vaccine on 4 separate occasions. The vaccine will be administered at rotating sites on the limbs or abdomen. The study will last approximately 12 months.
- Conditions
- Neoplasms by Site, Metastatic Cancer
- Being tested
- P10s-PADRE
- Medical subject headings
- Neoplasms by Site, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P10s-PADREDrug
Also called MONTANIDE ISA 51 VG
All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection for a total of 4 vaccinations.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination: P10s-PADRE/MONTANIDE ISA 51 VG | Experimental | 100mL vaccination on Weeks 1, 2, 3 and 8 Receives: Drug: P10s-PADRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Immune Response
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start1 Mar 2021
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms by SiteStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Issam Makhoul, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003195
- Sponsor's protocol ID
- 206265
- Status last verified
- Mar 2021
- First submitted
- 19 Dec 2016
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Phase I/II Study of a Carbohydrate Mimotope-Based Vaccine with MONTANIDE™ ISA 51 VG STERILE for Metastatic Cancer
- ClinicalTrials.gov ID
- NCT03003195
- Acronym / sponsor ID
- 206265
- Conditions
- Neoplasms by Site, Metastatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 26 Dec 2016 (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 purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer.
Detailed description
After signing Institutional Review Board (IRB) approved consent, subjects with metastatic cancer will be enrolled. The vaccine doses will be prepared and dispensed by the University of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions. Subjects will receive 1.0 mL subcutaneous injections of the vaccine on 4 separate occasions. The vaccine will be administered at rotating sites on the limbs or abdomen. The study will last approximately 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination: P10s-PADRE/MONTANIDE ISA 51 VG | Experimental | Drug: P10s-PADRE100mL vaccination on Weeks 1, 2, 3 and 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects of all races with clinical Stage IV cancer of any type, staged according to American Joint Commission on Cancer (AJCC), sixth edition, receiving any line of standard treatment for the specific cancer and with stable disease or better for at least two months will be invited to participate.
- Subjects of all races with clinical Stage IV cancer of any type, staged according to American Joint Commission on Cancer (AJCC), sixth edition, who have no standard treatment options for the specific cancer (Patients whose standard of care consists of watchful waiting) and who fulfill the other eligibility criteria will be invited to participate.
- Measurable or evaluable disease.
- Patients with bone-only disease will be allowed to participate.
- Ages 18 years and older.
Key exclusion criteria (8 listed)
- Active infection requiring treatment with antibiotics.
- Existing diagnosis or history of organic brain syndrome that precludes participation in the full protocol.
- Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol.
- Other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ, or basal or squamous skin cancer are eligible, provided they are disease-free of these other malignancies at the time of registration. Subjects with other malignancies - other than the one for which they are being treated - are eligible if they have been continuously disease free (from the old cancer) for ≥ 5 years prior to the time of registration.
- Existing diagnosis or history of autoimmune disorders or conditions of immunosuppression. This includes, but is not limited to, being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in standard therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who have been on systemic steroids will require a 6-week washout period. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.
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 |
|---|---|---|
| P10s-PADREAlso: MONTANIDE ISA 51 VGAll research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection for a total of 4 vaccinations. | Drug | Vaccination: P10s-PADRE/MONTANIDE ISA 51 VG |
Primary outcome
Number of Participants with Immune Response
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- 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.
Issam Makhoul, MD principal investigator
University of Arkansas
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing P10s-PADRE in people with Neoplasms by Site and Metastatic Cancer, run by University of Arkansas.
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 12 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 Immune Response (time frame: 12 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 3 Sep 2024.