Viral Therapy in Treating Patients With Metastatic Melanoma

NCT00651157 | Completed Phase 2 Results DMC

• 6 other identifiers: NCI-2009-00233MAYO-MC06727848CDR0000592801MC0672N01CM00070
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying the side effects and how well viral therapy works in treating patients with metastatic melanoma. Viral therapy may be able to kill tumor cells without damaging normal cells.

Conditions

Recurrent Melanoma; Stage IV Melanoma

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  A tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.

  Every 4 weeks after 4 courses of treatment, assessed up to 5 years

Secondary Outcomes (2)

• Overall Survival

  Time from registration to death due to any cause, assessed up to 5 years

• Time to Disease Progression

  Time from registration to documentation of disease progression, assessed up to 5 years

Study Arms (1)

Treatment (viral therapy)

EXPERIMENTAL

Patients receive wild-type reovirus (Reolysin®) IV administered at a dose of 3 x 10\^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Biological: wild-type reovirus

Interventions

wild-type reovirus BIOLOGICAL

Given IV: Administered at a dose of 3 x 10\^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle.

Also known as: REOLYSIN

Treatment (viral therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed malignant melanoma
• All melanomas, regardless of origin, are allowed
• Metastatic disease
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• Must have ≥ 1 metastatic lesion that can be safely biopsied
• Must have received ≥ 1 prior treatment for metastatic disease
• Not a candidate for curative surgery for metastatic disease
• No known brain metastases
• Eastern Cooperative Oncology Group performance status 0-2
• Life expectancy \> 12 weeks
• Total White Blood Cell (WBC) ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

reolysin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Evanthia Galanis, M.D.
• Organization: Mayo Clinic Cancer Center

galanis.evanthia@mayo.edu

Study Officials

• Evanthia Galanis

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 2, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: October 1, 2012
• Last Updated: April 22, 2014
• Results First Posted: October 16, 2013

Record last verified: 2014-02

Locations

US (1)