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


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer, Melanoma (Skin)

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Metabolic activity at visceral sites

Safety Issue:

No

Principal Investigator

Richard E. Royal, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Food and Drug Administration

Study ID:

060099

NCT ID:

NCT00316901

Start Date:

April 2006

Completion Date:

December 2007

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • stage IV renal cell cancer
  • stage IV melanoma
  • recurrent melanoma
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182