18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma

Phase 2

Terminated

Conditions: Recurrent Adult Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma

Interventions: Radiation: fludeoxyglucose F 18
Other: 18F-fluoromisonidazole
Procedure: positron emission tomography
Procedure: computed tomography
Other: laboratory biomarker analysis

Registration Number: NCT01169350

Lead Sponsor: National Cancer Institute (NCI)

Brief Summary: This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors predict how well a patient will respond to treatment.

Detailed Description: PRIMARY OBJECTIVES:

I. Evaluate the potential of 18F-fluoromisonidazole (\[18F\] FMISO) as a non-invasive indicator of tissue hypoxia to provide tumor-imaging data that correlates with tissue markers of hypoxia in patients with soft tissue sarcoma treated with neoadjuvant chemotherapy with or without radiotherapy.

SECONDARY OBJECTIVES:

I. Test \[18F\] FMISO tumor uptake as an independent predictor of patient outcome and if it provides additional predictive power over fludeoxyglucose F 18 PET scan.

II. Test \[18F\] FMISO tumor uptake as a predictor of response in the subgroup of patients treated with radiotherapy and chemotherapy.

III. Test the reproducibility of \[18F\] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.

IV. Determine the relationship between hypoxia-related biomarkers (HIF1-a and VEGF), proliferation biomarkers (microvascular density, p53, and Ki-67), and regional \[18F\] FMISO uptake in tumor.

OUTLINE:

Patients undergo fludeoxyglucose F 18 \[18F\] FDG and 18F-fluoromisonidazole (\[18F\] FMISO) positron emission tomography (PET)/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.

NOTE: Some patients may undergo repeat \[18F\] FMISO PET/CT scan within 48 hours after the first \[18F\] FMISO scan to evaluate the variability (test-retest) of this imaging measurement.

Blood samples are collected after completion of \[18F\] FMISO and \[18F\] FDG PET/CT scans for laboratory biomarker studies by IHC assays. Tumor samples from biopsy or surgery are also collected for biomarker studies.

After completion of study procedures, patients are followed up periodically for 2 years.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

Inclusion Criteria

Histologically confirmed intermediate- or high-grade soft tissue sarcoma
- Biopsy proven or highly suspicious primary or recurrent disease
- Tumor size ≥ 2 cm
Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy
Life expectancy ≥ 12 months
Negative pregnancy test
Willing to undergo PET scanning
Willing to undergo possible urinary bladder catheterization (for patients with pelvic or proximal thigh tumors)
Able to lie on the imaging table for up to 1.5 hours
Weight ≤ 400 lbs
Not pregnant

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (18F FDG and 18F FMISO PET/CT)	positron emission tomography	Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.
Diagnostic (18F FDG and 18F FMISO PET/CT)	18F-fluoromisonidazole	Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.
Diagnostic (18F FDG and 18F FMISO PET/CT)	laboratory biomarker analysis	Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.
Diagnostic (18F FDG and 18F FMISO PET/CT)	fludeoxyglucose F 18	Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.
Diagnostic (18F FDG and 18F FMISO PET/CT)	computed tomography	Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.

Primary Outcome Measures

Name	Time	Method
Changes From Baseline Hypoxic Volume (HV)	Baseline and up to 2 years	ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 2 years	Multivariate Cox regression will be used. The outcome is binary and generalized linear models and logistic regression will be employed.
Disease Free Survival	From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years	Multivariate Cox regression will be used.
Response to Radiation Therapy (XRT) by RECIST Criteria	Up to 2 years	Will be approached using multivariate logistic regression.

Trial Locations

Locations (2): Seattle Cancer Care Alliance
🇺🇸
Seattle, Washington, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States