Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Part of paid clinical trials in Duarte, California.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT01258855
- Phase
- PHASE2
- Status
- Completed
Conditions
- Metastatic Melanoma
- Recurrent Melanoma
- Stage III Cutaneous Melanoma AJCC v7
- Stage IIIA Cutaneous Melanoma AJCC v7
- Stage IIIB Cutaneous Melanoma AJCC v7
- Stage IIIC Cutaneous Melanoma AJCC v7
- Stage IV Cutaneous Melanoma AJCC v6 and v7
Eligibility Criteria
- Sex
- ALL
- Age
- 17 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aldesleukin — BIOLOGICALGiven IV
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Ziv-Aflibercept — BIOLOGICALGiven IV
Study Details
This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by blocking blood flow to the tumor. It is not yet known whether aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.
Key Dates
- Start date
- Jan 18, 2011
- Status verified
- May 2019
- Primary completion
- Mar 29, 2018
- Completion
- Mar 29, 2018
Study Design
- Enrollment
- 84 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm I (ziv-aflibercept and aldesleukin)Patients receive ziv-aflibercept IV over at least 1 hour in weeks 1, 3, 5, and 7 (and in week 9 of course 1 only) and high-dose aldesleukin IV over 15 minutes every 8 hours for 5 days in weeks 1 and 3 (and in weeks 3 and 5 of course 1 only). Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising ziv-aflibercept IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
- Experimental: Arm II (aldesleukin)Patients receive high-dose aldesleukin IV over 15 minutes every 8 hours for 5 days in weeks 1 and 3. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Progression-free Survival [ Time Frame: The time from the date of randomization until date of progression, death, or recurrence, assessed up to 5 years ]
Locations (21)
Find similar trials in Duarte, CA
By condition
By specialty
By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CACity of Hope South Pasadena· South Pasadena, CAEmory University Hospital/Winship Cancer Institute· Atlanta, GALurie Children's Hospital-Chicago· Chicago, ILNorthwestern University· Chicago, IL
Related Studies
- Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic MelanomaPHASE2 · Recruiting · Abramson Cancer Center at Penn Medicine · Lancaster, Pennsylvania
- Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid TumorsPHASE1 · Recruiting · Anusha Kalbasi · Duarte, California
- A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain MetastasesPHASE2 · Recruiting · SWOG Cancer Research Network · Birmingham, Alabama
- Intralesional Influenza Vaccine for the Treatment of Stage I-IV MelanomaPHASE1 · Recruiting · Carlo Contreras · Columbus, Ohio