A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma

Cancer Clinical Trial

Official title:

A Contiguous, Sequential Phase I/II Imaging Study of 18F-fluoro-3'-L-fluorothymidine (18F-FLT) in Patients With Known or Suspected Carcinoma of the Lung, Breast, Renal Cell, Pancreas, or Brain, and With Gastrointestinal Malignancies, Neuroendocrine Tumours or Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01065805
• Other study ID #: DX-FLT-002
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 20, 2009
• Est. completion date: February 25, 2019

Study information

• Verified date: February 2019
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.

Description:

Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: February 25, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.

• Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.

• Biochemical parameters as measured are required to be within 5 times the normal limits for age.

• Able and willing to follow instruction and comply with the protocol

• Provide written informed consent prior to participation in the study

• Karnofsky Performance Scale Score 50-100

Exclusion Criteria:

• Previous removal of entire tumour

• Biochemical parameters as measured outside 5 times the normal limits for age

• Unable or unwilling to follow instructions and comply with the protocol

• Unable or unwilling to provide written informed consent prior to participation in the study

• Karnofsky Performance Scale Score < 50

• Nursing or pregnant females

• Age less than 16 years

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Cancer
• Lymphoma
• Solid Tumor

Intervention

Biological:
• 18F-FLT
Phase I: Radioactive dose of 2.59 MBq/kg (111-222 MGq)per injection. A single injection of 18F-FLT and PET scan will be permitted per patient. Phase II: Radioactive dose of 2.59 MBq/kg (100-350) MBq per injection. Up to five separate injections of 18F-FLT and PET scans will be permitted per patient

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: to determine the safety of 18 F-FLT.		3 years
Primary	Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores.		3 years
Secondary	Phase I: To determine general biodistribution of 19F-FLT		3 years
Secondary	Phase II: to confirm safety of 18F-FLT; to determine the relative uptake of 18F-FLT (SUV, RUS, T/N); and to correlate 18F-FLT uptake with patient outcomes.		3 years
Secondary	Phase II: to correlate 18F-FLT uptake with patient outcomes (treatment response, progression-free survival, overall survival), over the first 12 months of follow-up after completion of tx, subsequently over the remainder of the disease course		3 years