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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

Primary Purpose

Kidney Cancer, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
computed tomography
positron emission tomography
fludeoxyglucose F 18
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Cancer focused on measuring stage IV renal cell cancer, stage IV melanoma, recurrent melanoma, recurrent renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Outcomes

Primary Outcome Measures

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

Response of individual metastases in comparison with metabolic alterations

Full Information

First Posted
April 19, 2006
Last Updated
March 14, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00316901
Brief Title
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
Official Title
PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Melanoma (Skin)
Keywords
stage IV renal cell cancer, stage IV melanoma, recurrent melanoma, recurrent renal cell cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Primary Outcome Measure Information:
Title
Metabolic activity at visceral sites
Title
Metabolic activity at metastatic sites
Title
Differences in metabolic activity at visceral and metastatic sites in patients treated with intravenous and intraarterial cell infusions
Secondary Outcome Measure Information:
Title
Response of individual metastases in comparison with metabolic alterations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E. Royal, MD, FACS
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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