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Metastatic MelanomaPhase 2NCT00984464

Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

A Phase 2 study testing REOLYSIN, Carboplatin and Paclitaxel in people with Metastatic Melanoma, run by Oncolytics Biotech at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic virus in combination with paclitaxel and carboplatin is effective and safe in the treatment of metastatic melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
REOLYSIN, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
How many people
14 participants
Where
1 siteUnited States
Study dates
Sep 2009to Oct 2014
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

  • have histologically or cytologically confirmed metastatic malignant melanoma.
  • have measurable disease.
  • have failed at least one prior treatment for metastatic disease or not considered a candidate for standard first line treatment.
  • have not received previous carboplatin and/or paclitaxel chemotherapy.
  • have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures.
  • any surgery involving the melanoma (except biopsies) must have occurred at least 28 days prior to study enrolment.
Show all 13Show fewer
  • be at least 18 years of age.
  • have received NO chemotherapy, radiotherapy, immunotherapy or hormonal therapy within 28 days prior to receiving study drug
  • have ECOG Performance Score of ≤ 2.
  • have a life expectancy of at least 3 months.
  • absolute neutrophil ≥ 1.5 x 10^9; Platelets ≥ 100 x10^9; Hemoglobin ≥ 9.0 g/dL; Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN.
  • negative pregnancy test for females with childbearing potential.
  • be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.

Who cannot join

  • receive concurrent therapy with any other investigational anticancer agent while on study.
  • be good candidate for surgery with curative intent for metastatic disease.
  • have a history of or current evidence of brain metastasis(es).
  • be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
  • be a pregnant or breast-feeding woman.
  • have clinically significant cardiac disease.
  • have dementia or altered mental status that would prohibit informed consent.
  • have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer Therapy & Research Center at UTHSCSA

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 2 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic virus in combination with paclitaxel and carboplatin is effective and safe in the treatment of metastatic melanoma.

Read the detailed description

Cutaneous melanoma is one of the most rapidly increasing cancers in the US and around the world with an increase in incidence of about 3-7% per year for fair-skinned Caucasian populations. An estimated 62,480 cases of invasive melanoma will be diagnosed in the US in 2008 with an estimated 8,420 deaths. An additional 46,170 cases of melanoma in situ are predicted.

Melanoma that has spread to distant sites (stage IV) is rarely curable.

This Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with paclitaxel and carboplatin every 3 weeks in patients with metastatic melanoma.

Response is a primary endpoint of this trial.

Patients may continue to receive chemotherapy in combination with REOLYSIN for up to 8 cycles and may continue indefinitely on REOLYSIN monotherapy under this protocol, provided they have not experienced either progressive disease or unacceptable drug-related toxicity that does not respond to either supportive care or dose reduction.

Being tested
REOLYSIN, Carboplatin, Paclitaxel
Keywords
metastatic, melanoma, REOLYSIN, chemotherapy, carboplatin, paclitaxel
Medical subject headings
Melanoma, Neoplasm Metastasis

What participants receive

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

  • REOLYSINBiological

    3x10E10 TCID50, 1 hour intravenous infusion, administered on Days 1,2,3,4 and 5 of a 21-day cycle

  • CarboplatinDrug

    Also called Paraplatin®

    6 AUC mg/ml min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle

  • PaclitaxelDrug

    Also called Taxol®

    200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle

What is being measured

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

  1. Determine the antitumor effect in terms of objective response rates (i.e., partial response (PR) and complete response (CR) to treatment)

    Measured: must be confirmed 4 weeks after the criteria for response are first met.

Secondary outcomes (2)

  1. Evaluate the safety and tolerability of the treatment regimen in the study population.

    Measured: Within 30 days of last dose of REOLYSIN

  2. Assess progression-free survival (PFS) and overall survival (OS) and disease control [CR+PR+Stable Disease (SD)] rate and duration in the study population

    Measured: until death

Timeline

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

  1. First posted25 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionFeb 2014
  4. Study completionOct 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00984464
Sponsor's protocol ID
REO 020
Status last verified
Apr 2015
First submitted
24 Sep 2009
Last updated
10 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REOLYSIN, Carboplatin and Paclitaxel in people with Metastatic Melanoma, run by Oncolytics Biotech 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 13 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: finished, as of the sponsor's last update on 10 Apr 2015. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Determine the antitumor effect in terms of objective response rates (i.e., partial response (PR) and complete response (CR) to treatment) (time frame: must be confirmed 4 weeks after the criteria for response are first met.). 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 NCT00984464.

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 10 Apr 2015.

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