Investigational New Drugs Sponsorship for Cancer Treatments • FDA Approved

RITA Foundation is the sponsor of two new investigational New Drug (IND) applications approved by FDA for treatment of neuroendocrine cancers. These treatments are offered in collaboration with:

  • Excel Diagnostics based in Houston, Texas
  • BioSynthema Corporation based in St. Luis, Missouri
  • Advanced Accelerator Applications (AAA) based in France
  • Missouri University Research Reactor (MURR) based in Missouri
  • IsoTherapeutics Group (ITG) based in Angelton, Texas
  • IsoTexs based in Friendswood, Texas
  • South Texas Radio-Pharmacy based in Houston, Texas
  • Baylor College of Medicine based in Houston, Texas
  • St. Luke’s Episcopal Hospital based in Houston, Texas

RITA's Sponsored Treatments for Neuroendocrine Cancers

1. High Activity In-111 Octreotide Therapy

High activity In-111 Octreotide therapy for disseminated or non-operable neuroendocrine cancer, is an “off-Label use of previously approved In-111 Pentetreotide (Octreoscan®) in high doses for treatment.

2. Lu-177 Octreotate

Lu-177 Octreotate which has been available in Europe and Australia for many years and up to now patients had to go to Europe to receive this treatment.

Participation & Outcomes

More than 100 patients have been treated with high activity In-111 Octreotide with outcomes superior to conventional chemotherapy or cold Sandostatin. Therapy with lu-177 Octreotate was approved by FDA on August 18, 2010, and more than 20 patients have already enrolled and received treatment.

Patient Recruitment & Eligibility

Recruitment of patients is continued on both treatments. Please submit the following clinical and laboratory information if you would like to be evaluated for eligibility to receive Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine cancer:

  1. Pathology report from initial biopsy or surgery.
  2. Result of most recent Octreoscan.
  3. Recent reports of diagnostic imaging studies including CT scans, MRI, PET scans
  4. Most recent History and Physical report by your primary oncologists.
  5. Recent treatments and medications.

Please fax or email the information to:

Mrs. Susan Cork
Therapy Coordinator
Excel Diagnostics and Nuclear Oncology Center or 713-781-6206 (fax)

Neuroendocrine Tumors Overview

Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that arise from Kulchinsky cells that populate the thymus, bronchus and gut. Regardless of their primary site, NETs share similar histological, metabolic and ultrastructural features 1. Many NETs are found during surgery for other diagnoses, such as appendicitis, pancreatitis or small bowel obstruction. The average time from symptom onset to diagnosis is sometimes more than 9 years 2. The indolent nature of NETs lead most patients seek treatment for their tumor when it has already metastasized limiting their overall survival 3. Therapeutic options for patients with advanced disease are often limited. Single agent or combination chemotherapy regimens for management of “typical” slow growing NETs have not been efficacious. Furthermore, external-beam radiation therapy has not demonstrated significant efficacy in establishing local control in NETs. Interferon (IFN) therapy has also been used in protocol-based management of Carcinoid tumors with reported biochemical and tumor response rates of 40% and 12% respectively 4, 5. However, IFN therapy is associated with numerous toxicities including fever, anorexia, weight loss, fatigue and myelosuppression. Due to the high incidence of toxicity and the low tumor response rate, the routine use of IFN for NETs is rarely recommended in the USA.

Peptide Receptor Radionuclide Therapy (PRRT)

PRRT is a therapeutic approach that uses the affinity of special peptide (small protein) called Octreotide for targeting the NET tumor cells. When this peptide is attached to radioactive materials such as Indium-111, Lu-177 or Y-90, it can deliver significant amount of radiation specifically to tumor cells (Targeted Therapy). While medication is administered systemically, the radioactive peptide only resides at the site of the tumor cells, wherever they exist in the body, and washes out rapidly from the normal organs. Therefore, the therapeutic effect of radioactive material will occur in the region of the tumors with minimal and reversible effects on the normal tissue. This is the reason for typically mild side effects secondary to this treatment approach when is compared with systemic chemotherapy.

High Activity Indium-111 Octreotide Therapy

Indium-111 Octreotide is a radioactive labeled peptide (small protein) that has affinity for Somatostatin receptors which exist almost exclusively on the cell surface of Neuroendocrine cancer cells. This agent in low dose (about 5.0 mCi) is used as a diagnostic imaging test to identify the locations of the Neuroendocrine tumors. Significantly higher doses such as 500 mCi of this agent has been shown to have therapeutic effects on these tumors.

Excel Diagnostics and Nuclear Oncology Center in collaboration with RITA Foundation, Baylor College of Medicine, and St. Luke’s Hospital started treating patients with this agent in August of 2005. The treatment was under FDA oversight and approved Investigational New Drug Application. The result of our treatments on first 32 patients with at least 2 cycles of treatment with 500 mCi In-111 Octreotide was very promising and was published in Cancer Biotherapy and Radiopharmaceuticals in 2008. As of May of 2010 more than 100 patients have received up to 4 cycles of this treatment with majority of the patients with previous progressive disease achieving stable disease and significant improvement in their clinical symptoms. Our scientist are in the final stage of collecting the data on these patients which will be ready for publication in early 2011. For further information about this treatment and Insurance coverage for this therapy please contact Ms. Susan Cork at:

Lutetium-177 Octreotate Therapy

Lutetium -177 Octreotate is another somatostatin receptor seeking agent that can detect neuroendocrine tumor cells throughout the body, attach to them and delivers therapeutic dose of radioactivity to the tumor. This targeted radionuclide therapy has shown significant therapeutic effect on previously progressive tumors. Following is the results of the treatment on several hundred patients performed at Erasmus Medical Center in Netherlands:

“From January 2000 until August 2006 1772 treatments with lutetium-octreotate were given to a sum of 504 patients. Most patients had neuroendocrine tumours. A preliminary analysis in 310 patients with so-called gastroenteropancreatic tumours was performed after obtaining all results after finishing the treatment. This showed a decrease in the size of the tumours in 46% of patients, stable disease in 35% and progression of the tumour despite treatment in 20%. A significant improvement of quality of life in those patients with tumour regression was also noted. The average duration of the effect of therapy was 40 months, calculated from the start of therapy. In addition, there are strong indications that patients treated with Lutetium-octreotate, on average, survive several years longer (3-6 years) than patients who did not get this treatment. ”

Other centers in Europe including Germany, Switzerland, Italy, Sweden and others have also reported very promising results on the effectiveness and safety of this treatment option.

We at Excel Diagnostics and Nuclear Oncology Center are pleased to announce that we will have this treatment available for our patients in the United States in mid October of 2010. Please refer to our press release on August 18, 2010 regarding this exciting news.

Following is some information for our patients regarding this treatment at our center:

“Our protocol calls for 4 treatments every 6-9 weeks. For the first therapy, patients should expect staying 2 weeks in Houston. For the subsequent therapies, only one week. During their stay in Houston, patients will undergo all the protocol required imaging studies. We have to repeat the Octreoscan even patient has done it recently, since we have to do dosimetry with the study. A list of these studies will be sent to the referring physicians prior to the patient arrival in Houston. Lab request will be sent to the patients by our office, so they can do them before coming to Houston.

There are low cost but safe and clean facilities within one mile from our center that are currently housing our Indium therapy patients. Average cost per night is around $ 75.00 per night.

  1. We will need the following information to start the evaluation and registration:
  2. Patient demographics including patient contact and Insurance information.
  3. Pathology report of biopsy or surgical specimen.
  4. Recent Radiology imaging study reports.
  5. Recent Octreoscan report and preferably CD (Within one year is fine)
  6. Recent H&P including patient’s current medications.
  7. Recent labs including any marker studies.

We will have a brochure with all the necessary information ready for the patients and referring physicians in September of 2010. Please contact Excel clinical coordinators Susan Cork for further information and registration for this therapy.”