Positron Emission Tomography and CT Scan in Predicting Response in Patients With Metastatic Melanoma or Kidney Cancer Who Are Undergoing Cellular Adoptive Immunotherapy on a Surgery Branch Clinical Trial

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography scan (done before and after cellular adoptive immunotherapy), may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial is studying how well positron emission tomography and computed tomography scan predicts response in patients with metastatic melanoma or kidney cancer who are undergoing cellular adoptive immunotherapy on a Surgery Branch clinical trial.

Detailed Description
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OBJECTIVES: Primary Measure changes in metabolic activity at visceral sites during the acute treatment phase of adoptive cell transfer (ACT) using positron emission tomography (PET)/CT fusion imaging in patients with metastatic melanoma or renal cell cancer. Measure changes in metabolic activity at metastatic sites during the acute treatment phase of ACT using PET/CT fusion imaging. Compare the changes in metabolic activity at visceral and metastatic sites in patients treated with intravenous vs intra-arterial tumor-infiltrating lymphocyte infusions. Secondary Correlate response of individual metastases with these metabolic alterations. OUTLINE: This is a pilot study. Patients are stratified according to treatment (intravenous [IV] tumor-infiltrating lymphocytes [TIL] after a nonmyeloablative preparative regimen vs intra-arterial [IA] TIL after a nonmyeloablative preparative regimen vs IV TIL after a myeloablative preparative regimen with chemotherapy and total-body irradiation). Patients undergo positron emission tomography with fludeoxyglucose F 18 (FDG-PET)/CT fusion imaging at baseline (before starting TIL infusion), once between days 1-4 after TIL infusion, and once between days 5-8 after TIL infusion. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Official Title
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PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols

Conditions
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Kidney Cancer, Melanoma (Skin)

Intervention / Treatment
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* Procedure: computed tomography
* Procedure: positron emission tomography
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Melanoma Renal cell cancer Metastatic disease Measurable disease by CT scan or MRI Enrolled in a Surgery Branch protocol utilizing 1 of the following variations of adoptive cell transfer of tumor-infiltrating lymphocytes (TIL): Intravenous (IV) TIL after a nonmyeloablative preparative regimen (e.g., NCI-99-C-0158) Intra-arterial (IA) TIL after a nonmyeloablative preparative regimen (e.g., NCI-99-C-0158) IV TIL after a myeloablative preparative regimen with chemotherapy and total-body irradiation (e.g., NCI-04-C-0288) PATIENT CHARACTERISTICS: ECOG performance status 0-2 No history of or treatment for diabetes mellitus No hypersensitivity or allergy to fludeoxyglucose F 18 Weight ≤ 350 lbs (136 kg) Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: See Disease Characteristics No treatment with both IV and IA TIL

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: computed tomography|nan|
|Procedure: positron emission tomography|nan|
|Radiation: fludeoxyglucose F 18|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic activity at visceral sites |  |  | 
| Metabolic activity at metastatic sites |  |  | 
| Differences in metabolic activity at visceral and metastatic sites in patients treated with intravenous and intraarterial cell infusions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of individual metastases in comparison with metabolic alterations |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, stage IV melanoma, recurrent melanoma, recurrent renal cell cancer