NCT00316901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

1.7 years

First QC Date

April 19, 2006

Last Update Submit

March 14, 2012

Conditions

Kidney CancerMelanoma (Skin)

Keywords

stage IV renal cell cancerstage IV melanomarecurrent melanomarecurrent renal cell cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Response of individual metastases in comparison with metabolic alterations

Interventions

computed tomographyPROCEDURE
positron emission tomographyPROCEDURE
fludeoxyglucose F 18RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsMelanomaCarcinoma, Renal Cell

Interventions

Magnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Richard E. Royal, MD, FACS

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
DIAGNOSTIC
Sponsor Type
NIH

Study Record Dates

First Submitted

April 19, 2006

First Posted

April 21, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(1)