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:
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
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Melanoma (Skin)
Procedure: computed tomography
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Response of individual metastases in comparison with metabolic alterations [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316901

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Richard E. Royal, MD, FACS National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00316901     History of Changes
Other Study ID Numbers: 060099, 06-C-0099, NCI-P6831, CDR0000470868
Study First Received: April 19, 2006
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
stage IV renal cell cancer
stage IV melanoma
recurrent melanoma
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Melanoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 15, 2014