Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.

Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in the detection of excised lymph nodes in patients with known melanoma and breast cancer. All patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and vital blue dye.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Navidea Biopharmaceuticals
• Treatments: Dextrans; Technetium Tc 99m Pentetate

Criteria

Inclusion Criteria:

1. The patient has provided written informed consent with HIPAA authorization.

2. The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.

3. The patient is at least 18 years of age at the time of consent.

4. The patient has an ECOG performance status of Grade 0 - 2 (see Appendix A).

5. The patient has a clinical negative node status at the time of study entry (i.e. T0-4, N0, M0, see Appendix D and E).

6. If of childbearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.

Melanoma Patients

7. The patient has a diagnosis of primary melanoma. Breast Cancer Patients

8. The patient has a diagnosis of primary breast cancer.

9. Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.

Exclusion Criteria:

1. The patient is pregnant or lactating.

2. The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0, see Appendix D and E).

3. The patient has a known hypersensitivity to Lymphazurin.

4. The patient has participated in another investigational drug study within 30 days of scheduled surgery.

Melanoma Patients

5. The patient has a tumor with a Breslow depth less than 0.75mm.

6. Patient has had preoperative chemotherapy, immunotherapy, or radiation therapy.

7. Patient has been diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin.

8. Patient has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma.

9. Patient has undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap, or skin graft of any type).

Breast Cancer Patients

10. The patient has bilateral primary breast cancers or multiple tumors within their breast.

11. Patient has had prior surgical procedures such as breast implants, reduction mammoplasty, or axillary surgery.

12. Patient is scheduled for bilateral mastectomy unless for cosmetic reasons and the contraindicated breast will not undergo lymph node mapping.

13. Patient has had preoperative radiation therapy to the affected breast or axilla.