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Hormone Refractory Prostate CancerPhase 1/2NCT00906243

RNActive®-Derived Therapeutic Vaccine

A Phase 1/2 study testing CV9103 in people with Hormone Refractory Prostate Cancer, run by University of Florida 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

This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an out-patient setting. The present study is one of two clinical trials of the RNActive®-derived vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first clinical trials conducted for this novel vaccine. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Hormone Refractory Prostate Cancer
What is being tested?
CV9103
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
May 2009to Dec 2010
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 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with documented history of hormone refractory prostate cancer as evidenced by three consecutive increases in serum PSA despite continued androgen ablative therapy. Serum testosterone levels must be less than 50 ng/dl
  • Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
  • Age greater than or equal to 18 yrs (Phase I and IIa) and less than or equal to 75 yrs (Phase IIa only)
  • ECOG (Eastern Cooperative Oncology Group) Grade of 0 or 1
  • Adequate Hematologic Function with:
  • WBC ≥ 3000 mm3
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  • hemoglobin ≥ 10mg/dl
  • platelets ≥ 100,000/mm3
  • Adequate Renal and Hepatic Function with:
  • serum creatinine ≤ 1.5 x Upper Limit of Normal
  • bilirubin < 2.0 mg/dl
  • Adequate Coagulation Parameters with:
  • Prothrombin INR < 1.5
  • Partial Thromboplastin Time < 1.5 x Institutional Upper Limit of Normal
  • Subjects will be advised to use barrier contraception while enrolled in the study and for one month after the last immunization.
  • Life Expectancy > 6 month

Who cannot join

  • Subjects who have received radiation therapy within 8 weeks of pretreatment evaluation. (There must be at least 12 weeks if prior therapy included 89-Strontium between any prior therapy and study entry.)
  • Subjects who have received chemotherapy, radiation therapy or biologic regimens within 8 weeks of pretreatment evaluation.
  • Subjects treated with any investigational agent within the past 30 days are excluded.
  • Subjects who have received active immunotherapy, such as Antigen Loaded Dendritic Cells, are excluded (Phase I only). In Phase IIa, Subjects who have received an active immunotherapy based on any of the antigens used in this study either as DNA, RNA or a protein/peptide-based vaccines are excluded. Subjects who have received any other active immunotherapy, such as Antigen Loaded Dendritic Cells, within 6 months prior to study entry are also excluded.
  • Subjects who have not recovered from radiation, chemotherapy, or immunotherapy toxicities.
  • Subjects with either previously irradiated or new CNS (central nervous system) metastases. (Pre-enrollment head CT is not required.)
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  • Subjects with a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
  • Subjects with serious intercurrent chronic or acute illness such as pulmonary [asthma or chronic obstructive pulmonary disease (COPD)] or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.
  • Medical or psychological impediment to probable compliance with the protocol.
  • Concurrent second malignancy other than non-melanoma skin cancer, or controlled superficial bladder cancer. In the event of prior malignancies treated surgically, the subject must be considered NED (no evidence of disease) for a minimum of 3 years prior to enrollment.
  • Subjects on steroid therapy (or other immunosuppressive agents such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression. Subjects must have had 8 weeks of discontinuation of any steroid therapy prior to enrollment.
  • Presence of an active acute or chronic infection, including symptomatic urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology).
  • Subjects with penicillin allergies

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida, College of Medicine

    Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Phase I/IIa Study of RNActive®-Derived Therapeutic Vaccine in Advanced or Metastatic Hormone Refractory Prostate Cancer

This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an out-patient setting. The present study is one of two clinical trials of the RNActive®-derived vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first clinical trials conducted for this novel vaccine.

The Phase I part of the study consists of a staggered inclusion of subjects in two cohorts of 3, to confirm the safety of the intended dose (320 µg RNA per antigen), with a lower dose to be considered in case of dose-limiting toxicity (DLT) being reported in greater than or equal to 2 out of 3-6 subjects; in this way, the recommended dose (RD) for the Phase IIa part of the study will be established. In the Phase IIa part of the study, additional subjects will be included at the RD, to confirm the safety and explore the activity of that dose.

Read the detailed description

Medical Need:

At present, no curative therapy is available for subjects with advanced or metastatic prostate cancer. Approximately 1 of every 3 men present with advanced or metastatic disease; therefore, current standard therapies are ineffective and new therapeutic approaches are warranted. There is ample evidence that active immunotherapy against cancer is safe and capable of stimulating potentially therapeutic immune responses in the cancer patient. Moreover, several Phase II immunotherapy trials have suggested clinical benefit by reducing the tumor mass or prolonging time to progression in subjects with advanced prostate cancer.

Potential Benefits:

CV9103 is an mRNA-based vaccine for the treatment of human prostate cancer that is based on CureVac's RNActive® technology. CV9103 encodes for 4 prostate specific antigens. Because these antigens are present in prostate cancer cells, they are appropriate targets for intervention. These antigens have been shown to correlate frequently with the progression of prostate cancer, and are known to be immunogenic in humans, where they induce antigen specific T-cell or B cell expansion.

As an RNA-based vaccine, CV9103 features several advantages over other approaches: it is highly specific, there is no restriction to the patient's MHC genotype, and it does not need to cross the nuclear membrane to be active. Finally, in the absence of reverse transcriptase, RNA can not be integrated into the genome.

CV9103 will be administered in 5 doses.

Being tested
CV9103

What participants receive

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

  • CV9103Biological

    CV9103 encodes for 4 prostate specific antigens.

Study groups in NCT00906243
Study groupRoleWhat they receive
CV9103ExperimentalCV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
Receives: Biological: CV9103

What is being measured

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

  1. Phase I: Assessment of Safety and Tolerability of the Trial Regimen

    Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0:

    1. All Categories equal or greater than grade 3
    2. Allergy/autoimmunity equal or greater than grade 2
    3. Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0.

    Measured: At Nine Weeks with Follow Up at One Year

Timeline

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

  1. First posted21 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2010
  4. Study completionDec 2010

Why it stopped: Study Closed after completion of Phase I

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00906243
Sponsor's protocol ID
CV-9103-002
Status last verified
Feb 2012
First submitted
14 May 2009
Last updated
4 Apr 2012
Data monitoring committee
No

Publications

  • Fotin-Mleczek M, Duchardt KM, Lorenz C, Pfeiffer R, Ojkic-Zrna S, Probst J, Kallen KJ. Messenger RNA-based vaccines with dual activity induce balanced TLR-7 dependent adaptive immune responses and provide antitumor activity. J Immunother. 2011 Jan;34(1):1-15. doi: 10.1097/CJI.0b013e3181f7dbe8.

    PubMed 21150709

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CV9103 in people with Hormone Refractory Prostate Cancer, run by University of Florida 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 16 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 4 Apr 2012. 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 30 Mar 2012). 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?

Phase I: Assessment of Safety and Tolerability of the Trial Regimen (time frame: At Nine Weeks with Follow Up at One Year). 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 NCT00906243, which also lists 1 linked publication.

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 4 Apr 2012.

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