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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| CINJ #080410 | Other Identifier | CINJ |
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Slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: When irradiated donor lymphocytes are infused into the patient they may help the patient's immune system kill tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.
OBJECTIVES:
OUTLINE: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment repeats every 8-16 weeks for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically for research studies, including immunophenotypic analysis of cells and assay for cytotoxic T-lymphocytes and natural killer-cell activity against target cells.
After completion of study treatment, patients are followed for 60 days.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irradiated allogeneic lymphocytes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic allogeneic lymphocytes | Biological | If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | With regard to responses, this trial will use a two-stage Simon's design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and Kinetics of Clinical/Radiological Response | 5 years | |
| Rate of Graft-vs-host Disease | 5 years |
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DISEASE CHARACTERISTICS:
Diagnosis of clear cell renal cell carcinoma
Measurable disease
Previously treated with high-dose aldesleukin OR not eligible for or refused such therapy
No brain metastases by MRI or CT scan
HLA-partially matched (e.g., ≥ 2/6 HLA A, B, Dr match) related donor available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Strair, MD, PhD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
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Three subjects were enrolled from March 2005 through February 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Irradiated Allogeneic Lymphocytes | therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Irradiated Allogeneic Lymphocytes | therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate | With regard to responses, this trial will use a two-stage Simon's design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted. | The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure. | Posted | 5 years |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Irradiated Allogeneic Lymphocytes | therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roger Strair, MD, PhD | Rutgers Cancer Institute of New Jersey | 732-235-8675 | strairrk@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Rate and Kinetics of Clinical/Radiological Response | The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure. | Posted | 5 years |
|
|
| Secondary | Rate of Graft-vs-host Disease | The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure. | Posted | 5 years |
|
|
| 1 |
| 3 |
| 2 |
| 3 |
| Positive lymphocyte culture | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain - Back | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain - Kidney | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |