Recurrent Melanoma Clinical Trial
Official title:
RADVAX: A Stratified Phase II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma
Verified date | January 2020 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.
Status | Terminated |
Enrollment | 23 |
Est. completion date | June 21, 2019 |
Est. primary completion date | November 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed diagnosis of melanoma - Previously treated or previously untreated stage IV melanoma by American Joint Committee on Cancer (AJCC) staging criteria - Presence of an index lesion between 1 and 5 cm - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 - Signed informed consent document - Adequate renal, hepatic, and hematologic indices for ipilimumab therapy - Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment) Exclusion Criteria: - Prior systemic therapy within 14 days of study enrollment; patients must be adequately recovered from prior systemic therapy side effects as deemed by the treating investigator - Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc) - Presence of central nervous system metastasis (including active brain metastasis); active brain metastasis would be defined as untreated brain metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active - Long-term use of systemic corticosteroids; patients with replacement steroids and not immunosuppressive steroids may enroll in the study - Prior radiation therapy (RT) that precludes the delivery of SBRT |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immune-related Clinical Response, Defined as Proportion of Patients Treated at the Maximum-tolerated Dose (MTD) Who Achieve Either a Complete or Partial Immune-related Response | Scored on a non-index lesion using immune-related response criteria according to immune-related Response Evaluation Criteria in Solid Tumors version 1.1. The number of immune-related responses will be tabled by stratum and SBRT fraction dose level. At the MTD, the immune-related response rate and 95% exact confidence interval will be estimated separately for previously untreated and previously treated metastatic patients. | Up to 60 days after last ipilimumab injection | |
Primary | Immune-related Progression-free Survival (irPFS) | irPFS will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD.. For some patients no scans were available for irRECIST reads, in which case change of management was determined to be the point of progression. |
Time from first day of radiotherapy to first documented immune-related progressive disease, death due to any cause or last patient contact alive and progression-free, assessed at 6 months | |
Primary | Late Toxicities, Graded According to the Radiation Therapy Oncology Group/European Organization for Research, the Treatment of Cancer Late Morbidity Scoring System, and the Common Terminology Criteria for Adverse Events Version 4.0 | Defined generally as an adverse event associated with the treatment which occurs beyond 30 days after last injection (i.e., adverse events which are observed months after treatment are most likely associated with SBRT). All dose-limiting toxicities and late toxicities will be graded and tabled by lesion site stratum and SBRT fraction dose level. Toxicity attribution to either SBRT or ipilimumab will be described if possible. | Up to 3 years | |
Primary | Overall Survival | Will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD. | Time from first day of radiotherapy to death due to any cause or last patient contact alive, assessed at 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02224781 -
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
|
Phase 3 | |
Completed |
NCT02107755 -
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT01886235 -
Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
|
N/A | |
Completed |
NCT00553306 -
Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma
|
Phase 1/Phase 2 | |
Completed |
NCT00121225 -
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
|
Phase 2 | |
Completed |
NCT00019448 -
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT01961115 -
Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma
|
Phase 2 | |
Completed |
NCT01748747 -
Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery
|
Early Phase 1 | |
Terminated |
NCT01316692 -
Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT01120275 -
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
Terminated |
NCT01217411 -
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
|
Phase 1 | |
Terminated |
NCT01166126 -
Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV
|
Phase 2 | |
Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
Completed |
NCT00288041 -
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00074308 -
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
|
Phase 1/Phase 2 | |
Completed |
NCT00072163 -
Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
|
Phase 2 | |
Completed |
NCT01989559 -
Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery
|
Phase 1 | |
Completed |
NCT00026143 -
Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
|
Phase 2 | |
Completed |
NCT00006243 -
Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma
|
N/A | |
Active, not recruiting |
NCT04284774 -
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
|
Phase 2 |