X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma
In this Phase I trial for subjects with advanced head & neck cancer, breast cancer, soft tissue sarcoma or melanoma all subjects will receive open label X-PACT treatment as a intra-tumoral injection. The primary objective will be to establish the safety of X-PACT when dosed with 5 intra-tumoral injections of the combination product (the phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) over a period of 6 weeks (on day D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6). After the week 8 tumor assessment subjects demonstrating stable disease, partial response or...
131I-Labeled MIBG for Refractory Neuroblastoma: A Compassionate Use Protocol
This is a compassionate use protocol to allow patients with advanced neuroblastoma palliative access to 131I-metaiodobenzylguanidine (131I-MIBG).
131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Relapsed/Refractory Neuroblastoma
This expanded access is the best available therapy/compassionate use designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are not eligible for therapies of higher priority. Patients may receive a range of doses depending on stem cell availability and tumor involvement of bone marrow. Response rate, toxicity, and time to progression and death will be evaluated.
131-I-MIBG Therapy for Refractory Neuroblastoma, Expanded Access Protocol
Metaiodobenzylguanidine (MIBG) is a substance that is taken up by neuroblastoma cells. MIBG is combined with radioactive iodine (131 I) in the laboratory to form a radioactive compound 131 I-MIBG. This radioactive compound delivers radiation specifically to the cancer cells and causes them to die. The purpose of this research protocol provides a mechanism to deliver MIBG therapy when clinically indicated, but also to provide a mechanism to continue to collect efficacy and toxicity data that will be provided. A recent New Approaches to Neuroblastoma Therapy (NANT) phase 2 randomized trial of 131I-MIBG with or without...
18F-FDOPA PET in Neuroendocrine Tumours
Neuroendocrine tumours (NETs) are a group of neoplasms generally arising from the gastroenteropancreatic tract. They are usually slow growing, have low malignant potential, and often go unnoticed until they become metastatic. The correct treatment approach is dependent on the extent of the disease, however surgical approaches and systemic therapy can be curative. Combined positron emission tomography/computed tomography (PET/CT) using the radiotracer 18F-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) has been shown to be a promising non-invasive technique to help localizing NETs and guide their treatment.
A Compassionate Use/Expanded Access Protocol Using 131I-MIBG Therapy for Patients With Refractory Neuroblastoma and Metastatic Pheochromocytoma
This is an expanded access protocol/compassionate use single institution study designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher priority. Response rate, toxicity, and time to progression and death will be evaluated.
An Intermediate Expanded Use Trial of DFMO
To provide DFMO in an expanded use setting to subjects with relapsed rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase.
Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection
The purpose of this Treatment Plan is to allow access to trametinib and dabrafenib for eligible high-risk BRAF mutation-positive patients in the adjuvant treatment of melanoma after surgical resection. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAFmutation-positive Metastatic Melanoma
The purpose of this Cohort Treatment Plan is to allow access to trametinib (monotherapy or in combination) and dabrafenib (monotherapy or in combination) for eligible patients diagnosed with metastatic melanoma BRAF mutation-positive.
EAP for the Treatment of Glioblastoma With PVSRIPO
This is an open-label, single-arm, non-randomized, intermediate-sized expanded access study evaluating the safety, efficacy, and tolerability of PVSRIPO delivered via intratumoral infusion, in subjects with glioblastoma (GBM) who are ineligible to participate in clinical study with PVSRIPO that is currently open to enrollment.