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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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00316901
First received: April 19, 2006
Last updated: March 14, 2012
Last verified: March 2012
History of Changes

April 19, 2006
March 14, 2012
April 2006
December 2007   (final data collection date for primary outcome measure)
  • Metabolic activity at visceral sites [ Designated as safety issue: No ]
  • Metabolic activity at metastatic sites [ Designated as safety issue: No ]
  • Differences in metabolic activity at visceral and metastatic sites in patients treated with intravenous and intraarterial cell infusions [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00316901 on ClinicalTrials.gov Archive Site
Response of individual metastases in comparison with metabolic alterations [ Designated as safety issue: No ]
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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
PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols

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.

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.
Interventional
Phase 2
Primary Purpose: Diagnostic
  • Kidney Cancer
  • Melanoma (Skin)
  • Procedure: computed tomography
  • Procedure: positron emission tomography
  • Radiation: fludeoxyglucose F 18
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316901
060099, 06-C-0099, NCI-P6831, CDR0000470868
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Not Provided
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Principal Investigator: Richard E. Royal, MD, FACS National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP