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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316901
• Other study ID #: 060099
• Secondary ID: 06-C-0099NCI-P68
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2006
• Last updated: March 14, 2012
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Melanoma (Skin)

Intervention

Procedure:
• computed tomography

• positron emission tomography

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic activity at visceral sites			No
Primary	Metabolic activity at metastatic sites			No
Primary	Differences in metabolic activity at visceral and metastatic sites in patients treated with intravenous and intraarterial cell infusions			No
Secondary	Response of individual metastases in comparison with metabolic alterations			No