Excel Diagnostics

Novel Targeted Peptide Receptor Radionuclide therapy (PRRT)  for Neuroendocrine Tumors.

Excel Diagnostics & Nuclear Oncology Center is pleased to offer  LU-177 DOTATATE for patients with Somatostatin Receptor (SSTR) Expressing Neuroendocrine tumors. Excel Diagnostics & Nuclear Oncology Center is the first research facility in North America to receive authorization to initiate this much needed cancer therapy under Investigational New Drug (IND) application from FDA in 2010. Excel also participated in the multicenter phase III, randomized clinical  trial of NETTER-1 for evaluation of effectiveness of Lu-177 DOTATATE (LutaThera®) sponsored by Advanced Accelerator Application (AAA) Pharmaceutical Company in U.S. Currently this treatment is provided to our patients under the Right To Try Law of the State of Texas, until the drug receives approval from FDA and be commercially available.

Excel Diagnostics and Nuclear Oncology Center under the directorship of Dr. Ebrahim S. Delpassand has the highest experience in performing PRRT in patients with neuroendocrine tumors in the United States and treated hundreds of patient with this rare disease.

For further information regarding this treatment please contact Ms. Susan Cork at scork@exceldiagnostics.com (phone: 713-341- 3203)or Ms. Amber Gonzales at agonzales@exceldiagnostics.com (Phone: 713-341-3246).

We at Excel Diagnostics & Nuclear Oncology Center are proud to be part of yet another exciting therapy in the fight against Neuroendocrine cancers.

Introduction and Background Information

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. One of the hallmarks of differentiated (mature) neuroendocrine tumors is expression of Somatostatin Receptors (SSTR). This provides an excellent opportunity to detect this disease and also treat this cancer by reaching these receptors on the surface of tumor cells. Somatostatin analogues are group of small molecules (Peptide) that have affinity for SSTR and therefore upon intravenous administration are capable of detecting tumor cells throughout the body and attach to the receptors. Attachment of radio-isotopes such as Lu-177 or Y-90 to this small molecule (Peptide) creates a radiopharmaceutical that is capable of reaching to SSTR expressing tumors at the cellular level and deliver the therapeutic doses of radiation to the tumors anywhere throughout the body, in a targeted fashion. This is considered a personalized and targeted cancer therapy since it is directed to the malignant cells with high effectiveness and less and mostly reversible side effects.    

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"Lutetium-177

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.

We will need the following information to start the evaluation and registration:

  1. Patient demographics including patient contact and Insurance information.
  2. Pathology report of biopsy or surgical specimen.
  3. Recent Radiology imaging study reports.
  4. Recent Octreoscan report and preferably CD (Within one year is fine)
  5. Recent H&P including patient’s current medications.
  6. 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, Ms. Susan Cork at scork@exceldiagnostics.com for further information and registration for this therapy. ”

"Information

Patients will be accepted for therapy according to the following inclusion and Exclusion criteria :

Inclusion Criteria

  1. Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial Carcinoid
  2. Presence of somatostatin-receptors on the know tumor lesions demonstrated by OctreoScan within 6 months of the first dose of radiolabeled Octreotate therapy. The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging.
  3. Life Expectancy greater than 12 weeks.
  4. Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma camera based) of ≥ 50ML/min.
  5. Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).
  6. Total Bilirubin ≤ 3X UNL.
  7. Serum Albumin > 30g/L or serum albumin ≤ 30g/L but normal prothrombin time.
  8. All patients must have a Karnofski performance status of at least 60%
  9. Patients must be greater than 18 years of age. Patients younger than 18 years will be presented to FDA for compassionate use on a case by case basis
    Exclusion Criteria

     

    1. Possible surgery with curative intent.
    2. Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of the start of therapy.
    3. Patients with known brain metastases unless these metastases have been treated and stabilized for at least 6months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.
    4. Uncontrolled congestive heart failure.
    5. Any subject who is taking concomitant medications which decrease renal function (such as amino-glycoside antibiotics).
    6. Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 3 months has been documented by modified RECISTS criteria as described in this study.
    7. Any subject receiving therapy with short acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radiolabeled somatostatin analogues, or any subject receiving therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radiolabeled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging.
    8. In patients with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be seeked for adequate further work-up.
    9. Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
    10. Prior radiation therapy to more than 25% of the bone marrow.
    11. Female patients who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 60 days (10 half lives of 177Lu after the last treatment, or male patients who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 60 days after the last treatment.

Inclusion and exclusion criteria cycles 2-4

Exclusion criteria cycles 2-4: all exclusion criteria for cycle 1 apply

Inclusion criteria cycles 2-4:

  1. Serum creatinine ≤150 μmol/liter or 1.7 mg/dL, or a measured creatinine clearance (or measured GFR) of ≥ 50 mL/min. Should a 40% increase over the Cycle 1/ Baseline serum creatinine value occur during the course of treatment , with a concomitant decrease of over 40% in creatinine clearance as calculated from serum creatinine concentrations according to Cockroft’s method, patients must also have a measured creatinine clearance (or GFR) performed.
  2. Hemoglobin (Hgb) concentration ≥ 5.0 mmol/L (≥8.0 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 75*109/L (75*103/mm3).
  3. Total bilirubin ≤3 x ULN.
  4. Serum albumin > 30 g/L, or serum albumin ≤ 30 g/L but normal prothrombin time.
  5. Karnofski Performance Status ≥ 60.

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"Xofigo

 Xofigo® (radium Ra 223 dichloride) injection is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

For Important Safety Information about Xofigo Therapy please click the following link:

Xofigo Therapy Safety Information

More information for Physician: Please click the following Link:

Physician Information about Xofigo

"Zevalin

 The ZEVALIN therapeutic regimen is used to treat patients with:

  • Recurring, low-grade or follicular B-cell NHL, after other anticancer drugs are no longer working.
  • Newly diagnosed follicular NHL following a response to initial anticancer therapy.

For Important Safety Information about Zevalin Therapy please click the following link:

 Zevalin Therapy Saftety Information

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Physician Information about Zevalin

"Samarium

This drug is used to help relieve bone pain in some types of cancer that have spread to the bones.

For Important Safety Information about Samarium Therapy please click the following link:

Samarium Therapy Safety Information

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Physician Information about Samarium

"Radioiodine

For Important Safety Information about Radioiodine Therapy please click the following link:

Radioiodine Therapy Safety Information

"

For Important Safety Information about this Therapy please click the following link:

Radioactive Iodine information