Kidney Cancer, Melanoma (Skin)
Conditions
Keywords
stage IV renal cell cancer, stage IV melanoma, recurrent melanoma, recurrent renal cell cancer
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.
Interventions
PROCEDUREcomputed tomography
PROCEDUREpositron emission tomography
RADIATIONfludeoxyglucose F 18
Sponsors
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Study design
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Response of individual metastases in comparison with metabolic alterations | — |
Countries
United States
Outcome results
None listed