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

Phase 2
18 Years
Open (Enrolling)
Metastatic Melanoma

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Trial Information

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

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

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.

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- receive concurrent therapy with any other investigational anticancer agent while on

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Devalingam Mahalingam, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Therapy & Research Center at UTHSCSA


United States: Food and Drug Administration

Study ID:

REO 020



Start Date:

September 2009

Completion Date:

October 2013

Related Keywords:

  • Metastatic Melanoma
  • metastatic
  • melanoma
  • chemotherapy
  • carboplatin
  • paclitaxel
  • Melanoma



Cancer Therapy & Research Center at UTHSCSA San Antonio, Texas  78229