PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols
18 Years
N/A
Both
Kidney Cancer, Melanoma (Skin)
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 Office | Bethesda, Maryland 20892-1182 |
