Evaluating hypoxia in primary melanoma
Prospective Evaluation of Hypoxia in Primary Melanoma
This study is trying to see if low oxygen levels in early-stage melanoma tumors can help predict how well patients will do after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | infliximab, chemotherapy, methotrexate, prednisone |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06831071 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate previous findings regarding the relationship between intra-nodal hypoxia and clinical outcomes in melanoma patients. It focuses on patients with early-stage melanoma who are undergoing standard procedures like wide local excision and sentinel lymph node biopsy. By analyzing banked samples and measuring hypoxia through carbonic anhydrase IX, the study seeks to determine if increased hypoxia correlates with worse progression-free survival. The goal is to understand how tumor metabolism may influence melanoma progression.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed early-stage melanoma who are scheduled for sentinel lymph node biopsy.
Not a fit: Patients with advanced melanoma or those not undergoing sentinel lymph node biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the metabolic behavior of melanoma, potentially leading to improved prognostic tools and treatment strategies.
How similar studies have performed: Previous studies have indicated a link between tumor hypoxia and clinical outcomes in melanoma, suggesting that this approach has potential based on earlier findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Must be willing and able to provide written informed consent for the study.
2. Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician.
3. Cutaneous or mucosal melanoma is permitted.
4. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.
1. Female subjects of childbearing potential must not be pregnant or breastfeeding. Female subjects will be considered of non-reproductive potential if they:
1. are postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
2. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening.
3. have a congenital or acquired condition that prevents childbearing.
2. Female and male subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and 1 week after the dose of study drug for females and 2 weeks for males by complying with one of the following:
1. practice abstinence from heterosexual activity
2. use (or have their partner use) acceptable contraception during heterosexual activity.
5. Adequate hematologic function: white blood cells (WBC) ≥ 2,500/μL, platelet count ≥ 100,000/μL, hemoglobin ≥ 8.0 g/dL
6. Adequate renal function: serum creatinine ≤ 2.0 mg/dL
7. Adequate hepatic function: serum alkaline phosphatase, bilirubin, and ALT ≤ twice the institutional upper limit of normal
Exclusion Criteria:
1. Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone \> 20 mg daily).
2. Severe septicemia or severe infection in the 4 weeks prior to study entry.
3. History of previous neuropathy from chemotherapy or other causes not related to cancer.
4. Pregnant subjects or breastfeeding subjects. (Note: A pregnancy test will be administered within 7 days prior to the administration of pimonidazole to female subjects of childbearing potential enrolled in the study.)
5. Subjects with (ECOG) Performance scale of 4 - subjects unable to perform self-care.
6. Subjects who have received an investigational new drug 6 half-lives or two weeks prior to enrollment in this study, whichever is shorter.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Yana M Najjar, MD — UPMC Hillman Cancer Center
- Study coordinator: Danielle L Bednarz, RN, BSN
- Email: bednarzdl@upmc.edu
- Phone: 4126231191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.