Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

NCT ID: NCT01925118

Last Updated: 2016-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Malignant Melanoma and Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-dose IL-2

Group Type EXPERIMENTAL

Irradiated donor lymphocyte infusion

Intervention Type BIOLOGICAL

Interventions

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Irradiated donor lymphocyte infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dae Seog Heo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1305-6130491

Identifier Type: -

Identifier Source: org_study_id

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