Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors

Launched by MICHAL ROLL · Jul 9, 2013

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with desmoid tumors, which are rare growths that can be difficult to manage. The study aims to see if taking a medication called 5-ALA before surgery, followed by a special light therapy during the surgery, can help reduce the chances of the tumor coming back after it has been removed. The researchers will also be checking how safe this treatment is for patients.

To be eligible for the study, participants need to be at least 18 years old and have a desmoid tumor that can be surgically removed. They can have previously received other treatments, like chemotherapy or surgery. However, individuals with certain medical conditions or those who are pregnant or breastfeeding cannot join the trial. If someone participates, they’ll be closely monitored to ensure their safety and to gather information about the treatment's effectiveness over a period of three years. This trial is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient has a resectable histologically confirmed desmoid tumor.
• • 2. Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.
• • 3. Age \> 18 years
• • 4. Signed informed consent prior to patient recruitment. -
• Exclusion Criteria:
• • 1. Hepatic enzymes or bilirubin \> 2X upper limit of normal.
• • 2. Serum creatinine \> 2.5 x upper limit of normal.
• • 3. Suspected /documented metastatic disease.
• • 4. Active or uncontrolled infections.
• • 5. Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) \< 2 years prior to the study.
• • 6. Use of other investigational agents \< 30 days prior to the study.
• • 7. Patients who are mentally or physically unable to comply with all aspects of the study.
• • 8. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
• • 9. Pregnant or lactating females.
• • 10. Known intolerance or allergy to 5-ALA
• • 11. Suspicious or documented acute or chronic porphyria