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Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

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ClinicalTrials.gov Identifier: NCT01925118
Recruitment Status : Terminated (Ineffectiveness)
First Posted : August 19, 2013
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Dae Seog Heo, Seoul National University Hospital

Brief Summary:
Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Melanoma and Renal Cell Carcinoma Biological: Irradiated donor lymphocyte infusion Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma
Study Start Date : August 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Experimental: High-dose IL-2 Biological: Irradiated donor lymphocyte infusion



Primary Outcome Measures :
  1. 12-week modified immune-related response rate [ Time Frame: 12-week ]

Secondary Outcome Measures :
  1. 6-week modified immune-related response rate [ Time Frame: 6-week ]
  2. Overall response rate based on RECIST v1.1 [ Time Frame: 6/12-week ]
  3. Progression-free survival [ Time Frame: 6-month ]
  4. Overall survival [ Time Frame: 1-year ]
  5. Immune-related adverse events [ Time Frame: 12-week ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed malignant melanoma or renal cell carcinoma
  • At stage IV or relapse
  • At least one prior chemotherapy including targeted agents
  • At least one haploidential or partially matched-HLA donor
  • ECOG performance status 0-1
  • Age 18-75 years
  • Measurable lesion
  • Adequate bone marrow, liver, and renal functions

Exclusion Criteria:

  • Chemotherapy within 4 weeks
  • Stem cell transplantation
  • Active CNS metastasis
  • Hypersensitivity to IL-2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925118


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Dae Seog Heo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01925118    
Other Study ID Numbers: H-1305-6130491
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases