Clinical Trials Logo
  1. Home
  2. Malignant Melanoma
  3. NCT01288963
  4. Details
NCT01288963 Clinical Trial

IL-2 "SELECT" Tissue Collection Protocol in Patients With Advanced Melanoma

Malignant Melanoma Clinical Trial

Official title:
The High-Dose Aldesleukin (IL-2) "SELECT" Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High-Dose IL-2 Treatments in Patients With Advance Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01288963
Other study ID # 09-333
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2010
Est. completion date December 2020

Study information
Verified date June 2023
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine which participants with melanoma have a better response to IL-2 and to identify markers that may predict response to IL-2 by collecting participant information (for example; cancer diagnosis and history, prior treatments for cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after treatment.

Description:

Original tumor slides will be collected to identify tumor markers that may predict responses to treatment. Blood samples will be obtained prior to treatment with IL-2.

Recruitment information / eligibility
Status Completed
Enrollment 153
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Malignant melanoma that is metastatic or unresectable - Eligible to receive high-dose IL-2 - Tissue block available with adequate tumor to perform RNA extraction and DASL analysis Exclusion Criteria: - Prior immunotherapy for unresectable or metastatic disease - Untreated brain metastases, leptomeningeal disease, or seizure disorder

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IL-2
Observation only

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high dose IL-2 based on therapy than the historical 16% response rate in an unselected patient population 2 years
Secondary To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response 2 years
Secondary To explore the predictive value of several genetic polymorphisms associated with immune function 2 years
Secondary To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2 2 years
Secondary To explore the relationship of serum fibronectin and VEGF levels with the molecular signature of immune responsiveness in patients with advanced melanoma receiving high-dose IL-2 in order to identify specific cohorts with dramatic differences in response 2 years
Secondary To identify new proteins or patterns of gene expression that might be associated with high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy to those who will benefit the most 2 years
See also
  Status Clinical Trial Phase
Completed NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT03653819 - High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs N/A
Active, not recruiting NCT04074096 - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis Phase 2
Completed NCT02935790 - Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab Phase 1
Recruiting NCT05478876 - Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract N/A
Completed NCT01211262 - Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma Phase 1
Recruiting NCT03649529 - Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy Early Phase 1
Completed NCT03278665 - 4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy Phase 1/Phase 2
Completed NCT04452214 - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Completed NCT01455259 - Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors Phase 1/Phase 2
Completed NCT00978913 - Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma Phase 1
Completed NCT00232726 - Clinical Study of Previously Untreated Patients With Malignant Melanoma Phase 2
Completed NCT00350597 - GM-CSF as Adjuvant Therapy of Melanoma Phase 2
Completed NCT00336986 - Efficacy Study of IL-21 to Treat Metastatic Melanoma Phase 2
Completed NCT02523313 - Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED Phase 2
Completed NCT03545334 - Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study N/A
Completed NCT04253574 - Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
Completed NCT00179608 - Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy Phase 1
Terminated NCT00104884 - FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma Phase 2