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Renal Cell CarcinomaPhase 2NCT00485563

A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma

A Phase 2 study testing EC90 (KLH-FITC), GPI-0100 and EC17 (Folate-FITC) in people with Renal Cell Carcinoma, run by Endocyte at 3 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

This is a Phase 2 clinical trial to collect data on tumor responses produced by folate-hapten conjugate therapy (vaccination with EC90 [KLH-FITC] and GPI-0100 adjuvant followed by treatment with EC17 (folate-FITC) in combination with low-dose cytokines in patients with progressive metastatic renal cell carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
EC90 (KLH-FITC), GPI-0100 and EC17 (Folate-FITC)
Type of treatment
Injection or infusion
How many people
12 participants
Where
3 sitesUnited States
Study dates
Jun 2007to Mar 2009
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

  • Must have a histologically confirmed diagnosis of renal cell carcinoma (clear cell or predominately clear cell component). Papillary histology may also be enrolled (maximum of 6 patients)
  • Must be diagnosed with relapsed or Stage IV disease that is medically or surgically unresectable and that has progressed after systemic therapy, including at least one agent in the general class of kinase inhibitors (TKI not required for papillary histology)
  • Must have measurable/evaluable metastatic disease sites that have not previously received radiotherapy and which does not require palliative intervention (at the time of enrollment). Patients with non-measurable/evaluable disease are ineligible
  • Must have at least one tumor lesion that displays uptake of 99mTc-EC20
  • Must be > than or = 18 years of age
  • Women must either be 1)not of child-bearing potential of 2)have a negative serum pregnancy test within 7 days prior to commencing treatment with investigational agents
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  • Must have completed prior cytotoxic chemotherapy, radiotherapy, immunotherapy or experimental therapy 30 or more days prior to study enrollment, and recovered (or returned to baseline) from associated acute toxicities. This restriction excludes palliative radiotherapy.
  • Must have an ECOG score less than or equal to 2
  • Must have adequate hematologic, renal, and heptic function

Who cannot join

  • Must not have a history of severe hypersensitivity (grade 3 - 4 allergic reaction) to fluorescein, radiological contrast agent, cytokines, or have received fluorescein within 30 days of the study
  • Must not have medical conditions that preclude the use of IL-2 or IFN-α.
  • Must not be pregnant or breast-feeding
  • Must not be currently undergoing chemotherapy, anticancer hormonal therapy, and/or therapy with immunosuppressant agents
  • Must not be currently receiving bisphosphonates such as Zometa® (unless started > four weeks prior to treatment with EC90/GPI-0100, in which case they can be continued)
  • Must not have any concomitant malignancy with the exception of basal cell or squamous cell carcinoma of skin
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  • Must not have radiographically documented evidence of current brain metastases, a history of stem cell transplant, immunodeficiency, and/or a medical or psychiatric illness (that in the investigator's opinion, would prevent adequate compliance with study therapy or evaluation of the endpoints)
  • Must not have been administered another radiopharmaceutical that would interfere with the assessment of 99mTc-EC20
  • Must not be unable to tolerate conditions for radionuclide imaging

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

Other trials in United States

About this study

This is a Phase 2 clinical trial to collect data on tumor responses produced by folate-hapten conjugate therapy (vaccination with EC90 [KLH-FITC] and GPI-0100 adjuvant followed by treatment with EC17 (folate-FITC) in combination with low-dose cytokines in patients with progressive metastatic renal cell carcinoma. All patients will undergo imaging with the investigational imaging agent 99mTc-EC20 (FolateScan) during the screening period to confirm eligibility for the treatment portion of the clinical trial.

Read the detailed description

Rationale: This is a Phase 2 study of folate-hapten conjugate therapy in combination with low-doses of the cytokines Interleukin-2 (IL-2) and Interferon-alpha (INF-alpha). Folate-hapten conjugate treatment consists of subcutaneous vaccinations with EC90, a compound designed to elicit an immune response (antibodies) to a dye called fluorescein (FITC), in combination with GPI-0100 adjuvant (a drug intended to improve antibody production). Vaccination is followed by treatment with EC17, a drug made by linking folate (a vitamin) with FITC. Experimental evidence has shown that the folate receptor is over-expressed in many human cancers, including renal cell carcinoma. It is expected that EC17 will attach to cancer cells through the folate receptor and that antibodies to FITC will recognize the cancer cell and mark it for destruction by the body's immune system. Two drugs, IL-2 and IFN-alpha, will be administered at low doses in combination with EC17 in order to boost the immune response. During the screening period, all potential patients will undergo imaging with 99mTc-EC20 (a technetium-based, folate- linked radiopharmaceutical [EC20]) for the purpose of identifying patients whose tumors express the folate receptor; the target of folate-hapten conjugate therapy. Prior to receiving EC90/GPI-0100 and EC17 therapy, patients must exhibit at least one tumor lesion that displays adequate uptake of 99mTc-EC20 during the imaging procedure.

Being tested
EC90 (KLH-FITC), GPI-0100, EC17 (Folate-FITC), Interleukin-2, Interferon-alpha
Keywords
Cancer, Vaccine, Phase 2, folate-hapten conjugate, Progressive, Metastatic, Experimental
Medical subject headings
Carcinoma, Renal Cell, Neoplasms, Neoplasm Metastasis

What participants receive

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

  • EC90 (KLH-FITC)Biological

    Also called Keyhole limpet hemocyanin fluorescein

    1.2mg in combination with adjuvant GPI-0100 administered subcutaneously (beneath the skin) weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.

  • GPI-0100Biological

    Also called Saponin-based adjuvant

    3.0 mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.

  • EC17 (Folate-FITC)Drug

    Also called folate-fluorescein conjugate;, folate-hapten conjugate

    0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks for the first two treatment cycles and then 3 days per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

  • Interleukin-2Drug

    Also called IL-2, Proleukin

    7.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 2.5 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

  • Interferon-alphaDrug

    Also called IFN-alpha, Intron-A

    3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.

What is being measured

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

  1. Response Rate - the proportion of subjects with objective response based on RECIST criteria

    Measured: A minimum of 13 weeks (time to first follow-up CT)

Secondary outcomes (3)

  1. To assess the safety and tolerability of folate-hapten conjugate therapy

    Measured: Duration of study drug administration + 30 days

  2. Time-to-progression, response duration, overall survival time observed after folate-hapten conjugate therapy and ECOG performance status

    Measured: Up to 2 years following completion of therapy

  3. To assess the safety and tolerability of 99mTc-EC20

    Measured: Duration of study drug administration + 7 days

Timeline

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

  1. First posted13 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionAug 2008
  4. Study completionMar 2009

Why it stopped: Changes in treatment paradigm resulted in a lower than expected rate of 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00485563
Sponsor's protocol ID
EC-FI-004
Status last verified
Mar 2012
First submitted
11 Jun 2007
Last updated
8 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EC90 (KLH-FITC), GPI-0100 and EC17 (Folate-FITC) in people with Renal Cell Carcinoma, run by Endocyte at 3 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 9 inclusion and 9 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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study was stopped early (reason given: Changes in treatment paradigm resulted in a lower than expected rate of accrual.). Results are not available in the source record.

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?

Response Rate - the proportion of subjects with objective response based on RECIST criteria (time frame: A minimum of 13 weeks (time to first follow-up CT)). 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 NCT00485563.

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 8 Mar 2012.

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