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Progressive Solid MalignanciesPhase 1/2NCT02224599

Cyclophosphamide, TAPA-Pulsed Dendritic Cell Therapy and Imiquimod in Progressive and/or Refractory Solid Malignancies

A Phase 1/2 study testing TAPA-pulsed DC vaccine, Cyclophosphamide Pill and Imiquimod Topical Cream in people with Progressive Solid Malignancies and Refractory Solid Malignancies, run by Kiromic BioPharma Inc. at 1 site 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

Patients diagnosed with progressive and/or refractory solid malignancies, who have failed conventional therapy, and have no available, potentially curative therapeutic options, will be candidates for this Phase I/II study. Read more about this study

Who is it for?
Any age
What is being tested?
TAPA-pulsed DC vaccine, Cyclophosphamide Pill and Imiquimod Topical Cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
28 Jul 2017to 30 Aug 2018
Phase
Phase 1/2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Ability to provide informed consent.
  • Patients with histologically proven progressive and/or refractory SM, s/p conventional salvage therapy, completed at least 3 weeks prior to study vaccination, will be eligible for enrollment.
  • Expression of one (1) or more of the following TAPAs: Sp17, AKAP-4, Ropporin, PTTG-1, Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1, by either RT-PCR and/or immunocytochemistry, Western blotting or ELISA, in neoplastic cells and/or blood. For HER-2/neu expression, positive FISH results are acceptable.
  • Presence of measurable or evaluable disease.
  • Patients must not have any active infectious process.
  • Patients must not have a history of HIV, or active Hepatitis A, B, and C.
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  • Patients must not be receiving active immunosuppressive therapy.
  • Patients must have discontinued systemic cytotoxic or radiation therapy at least three (3) weeks prior to vaccination and toxicities from previous therapies must be grade 1 or less. all other FDA approved forms of antineoplastic therapy are allowed such as immunotherapy, targeted therapies, or hormonal therapies (67, 68)
  • Patients may not have any known allergy to CYP and/or Imiquimod.
  • Patients must be willing to provide at least 250 mL, and up to 500 mL, of whole blood obtained by phlebotomy and/or consent to leukapheresis for DC generation.
  • Adequate renal and hepatic function (creatinine ≤ 2.0 mg/dl, bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 4X upper limit of normal range).
  • Adequate hematologic function (Platelets ≥ 60,000/mm3, lymphocytes ≥ 1,000 mm3, neutrophils ≥ 750/mm3, hemoglobin ≥ 9.0 g/dl).
  • Karnofsky performance status ≥ 70%.
  • Expected survival ≥ 6 months.
  • Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.

Who cannot join

  • Patients without confirmed progressive and/or refractory SM using standard RECIST criteria.
  • Patients without measurable or evaluable disease.
  • Patients receiving cytotoxic therapy or radiation therapy, within three (3) weeks of vaccination.
  • Active immunosuppressive therapy, including non-physiologic systemic steroids (excluding topical, intraocular, inhaled, and intranasal steroids) for any other condition.
  • Persistent fever (>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment.
  • Active ischemic heart disease or history of myocardial infarction within six months.
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  • Active autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), Inflammatory Bowel Disease (IBD) and Rheumatoid Arthritis (RA).
  • Pregnancy or breast feeding.
  • Active second invasive malignancy, other than basal cell carcinoma of the skin.
  • Life expectancy of less than 6 months.
  • Patients with contraindications to CYP and/or Imiquimod.
  • Patients who have received organ transplants.
  • Patients with psychological or geographic conditions that prevent adequate follow- up or compliance with the study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    San Antonio, Texas, 78240

Other trials in United States

About this study

Official title: Phase I/II Study of Low-Dose Cyclophosphamide, Tumor Associated Peptide Antigen-Pulsed Dendritic Cell Therapy and Imiquimod, in Patients With Progressive and/or Refractory Solid Malignancies

Patients diagnosed with progressive and/or refractory solid malignancies, who have failed conventional therapy, and have no available, potentially curative therapeutic options, will be candidates for this Phase I/II study. Following confirmation of disease progression and/or refractoriness, eligible patients who agree to participate and sign an informed consent form will have their tumor cells/tissues and/or blood analyzed for the expression of a specific panel of Tumor Associated Peptide Antigens (TAPAs), including Sp17, ropporin, AKAP-4, PTTG1, Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1.

Read the detailed description

For patients whose tumors express one (1) or more of these TAPAs (Sp17, ropporin, AKAP-4, PTTG1, Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1), whole blood will be obtained by phlebotomy and/or leukapheresis performed for generation of autologous DCs. Patient's DCs will be generated in Kiromic's Cell Processing GMP facility, according to established Standard Operating Procedures, and activated by pulsing/loading them with the TAPA(s) relevant for each particular patient. Patients will receive five (5) days of low-dose cyclophosphamide 5 to 7 days prior to each vaccination with TAPA-pulsed DCs to decrease Treg activity. Patients will also receive a single dose of topical Imiquimod cream after each vaccination. TAPA-pulsed DCs will be administered at a fixed dose of up to 1 X 107 DCs. DC vaccination schedule will be weekly via intradermal (ID) injections for a total of 3 vaccinations. Topical Imiquimod cream will also be administered once after the vaccination. Patients will be followed on a weekly basis (or more frequently if required) to evaluate treatment-related toxicity. Immune efficacy and anti-tumor responses will be evaluated per protocol specifications. Continuation and stopping rules for the study will be defined based on toxicity/tolerability (Phase I) and immune efficacy (Phase II).

Being tested
TAPA-pulsed DC vaccine, Cyclophosphamide Pill, Imiquimod Topical Cream
Keywords
Immunotherapy, TAPA-Pulsed Dendritic Cell Therapy, Dendritic Cell Therapy
Medical subject headings
Neoplasms

What participants receive

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

  • TAPA-pulsed DC vaccineBiological

    Subjects will given the vaccine which contains 1 x 10^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly.

  • Cyclophosphamide PillDrug

    Also called Cytoxan®, Neosar®

    Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle.

  • Imiquimod Topical CreamDrug

    Also called Aldara Cream, Zyclara

    Topical Imiquimod Cream will be applied after vaccination.

Study groups in NCT02224599
Study groupRoleWhat they receive
CYP, TAPA-pulsed DC vaccine, ImiquimodExperimentalTAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream
Receives: Biological: TAPA-pulsed DC vaccine; Drug: Cyclophosphamide Pill; Drug: Imiquimod Topical Cream

What is being measured

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

  1. Adverse Events Due to Administration of TAPA-Pulse DC Vaccine

    Grade, causality, start/stop dates (duration), resolutions for adverse events will be monitored and recorded.

    Measured: Continuous for 45 days after the first dose.

Secondary outcomes (2)

  1. Immune Response

    The response of T-cells present in the peripheral blood mononuclear cells (PBMCs) population to the peptides used to pulse a patient's dendritic cell vaccine is evaluated by measuring the expression of Th1/CTL-type cytokines (IFN-γ and/or TNF-α and/or IL-17) by a standard ELI-Spot assay using 500,000 PBMCs per experimental replicate and a minimum of 3 experimental replicates for each stimulation. The results are expressed as the average number of spots obtained from the stimulation of 500,000 PBMCs

    Measured: Days -7, 22 and 45

  2. Positive DTH Skin Tests With Relevant TAPA

    DTH skin test will be performed on subject's forearm or within 5 cm from the site of prior DC vaccination, if possible

    Measured: Days -7, 22 and 45

Timeline

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

  1. First posted25 Aug 2014 (estimated)
  2. Study start28 Jul 2017
  3. Primary completion30 Aug 2018
  4. Study completion30 Aug 2018

Why it stopped: Sponsor decision to terminate study due to poor accrual

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02224599
Sponsor's protocol ID
KIROVAX-003
Status last verified
Mar 2020
First submitted
11 Aug 2014
Last updated
24 Apr 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAPA-pulsed DC vaccine, Cyclophosphamide Pill and Imiquimod Topical Cream in people with Progressive Solid Malignancies and Refractory Solid Malignancies, run by Kiromic BioPharma Inc. 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 15 inclusion and 13 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 24 Apr 2020. 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 combined 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.

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 24 Apr 2020). 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?

Adverse Events Due to Administration of TAPA-Pulse DC Vaccine (time frame: Continuous for 45 days after the first dose.). 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 NCT02224599.

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 24 Apr 2020.

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