Kidney/Renal Cancer

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Combined Haploidentical Reduced Intensity Bone Marrow and Kidney Transplantation for Patients With Chronic Kidney Disease and Advanced Hematological Disorders


Condition: Chronic Kidney Disease, Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL), Hodgkin Disease, Multiple Myeloma, Myelodysplastic Syndrome (MDS), Aplastic Anemia, AL Amyloidosis, Diamond Blackfan Anemia, Myelofibrosis, Myeloproliferative Disease, Sickle Cell Anemia, Autoimmune Diseases, Thalassemia

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01758042

Sponsor: Massachusetts General Hospital

Eligibility:

  • Age: minimum 18 Years maximum 70 Years
  • Gender: All

Inclusion Criteria:

  • Patients ages 18-70
  • Underlying hematological disorder which is potentially curable with allogeneic bone marrow transplantation. This includes, but is not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS), AL amyloidosis, diamond blackfan anemia, myelofibrosis or other myeloproliferative disease, sickle cell anemia, and thalassemia.
  • Existence of haploidentical first degree relative who passes standard donor evaluations for bone marrow and kidney donation
  • LVEF > 40% as measured by echocardiography or MUGA
  • FEV1, FVC, and DLCO > 50% of predicted as measured by standard PFTs
  • Total bilirubin < 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all < 5x institutions upper limit of normal
  • ABO compatibility in the host vs. graft direction
  • Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.
  • Participants should be on dialysis or have an estimated or measured CrCl < 35 ml/min
  • Life expectancy greater than six months.
  • Recipient ability to understand and provide informed consent

Exclusion Criteria:

  • Active serious infection
  • Participation in other investigational drug use at the time of enrollment
  • Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to rabbit serum in ATG)
  • Serologic positivity for HIV, HCV, or HbsAg positivity
  • ABO blood group incompatibility in the host-vs-graft direction
  • Active serious infection

View trial on ClinicalTrials.gov


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177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.


Condition: Thyroid Cancer, Medullary, Neuroendocrine Tumor of the Lung Grade 1 and 2, Neuroendocrine Tumor of the Thymus Grade 1 and 2, Neuroendocrine Tumor GEP Grade 1-3

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02088645

Sponsor: University Hospital, Basel, Switzerland

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Phase 0 study
  • Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy or
  • Patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2) with low or missing expression of SST2-receptor and progressive disease within the last 6 months according to RECIST 1.1
  • Age > 18 years
  • Informed consent Phase I study
  • Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks
  • Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy- Age > 18 Years
  • Informed consent
  • Curative surgical therapy not possible

Exclusion Criteria:

  • Phase 0 study
  • Medication with Vandetanib 3 weeks before the study and during the study
  • Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface).
  • Bone marrow failure (thrombocytes < 70 000/μl, leucocytes < 2 500/μl, hemoglobin < 8 g/dl).
  • Pregnancy and breast feeding
  • Knows allergic reaction on Physiogel or other gelatine products
  • Known, serious side reaction in the case of a former application of pentagastrin
  • Active, second malignancy oder remission after second malignancy < 5 years Phase I study
  • Medication with Vandetanib 3 weeks before the study and during the study
  • Renal failure (calculated GFR < 50 ml/min per 1.73 m2 body surface).
  • Bone marrow failure (thrombocytes < 100 000/μl, leucocytes < 3 000/μl, hemoglobin < 10 g/dl).
  • Pregnancy and breast feeding
  • Known, serious side reaction in the case of a former application of pentagastrin
  • Active, second malignancy oder remission after second malignancy < 5 years

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An Open-label Phase II Study of Lutetium-177 [DOTA0, Tyr3] Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours


Condition: Carcinoma, Neuroendocrine

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01876771

Sponsor: AHS Cancer Control Alberta

Phase: Phase 2

Eligibility:

  • Age: minimum 14 Years maximum 90 Years
  • Gender: All

Inclusion Criteria:

  • 1. Male or female ≥ 14
  • 90 years of age. 2. Presence of somatostatin receptor positive tumour(s) on radionuclide imaging, with uptake greater than liver background as assessed by planar Octreoscan® images or Ga-68 labelled somatostatin analogue (68Ga-DOTATATE or 68Ga-HA-DOTATATE) PET imaging, with at least 1 tumour site reliably evaluable by CT or magnetic resonance imaging (MRI) of at least 1.0 cm (smallest dimension) or >1.5 cm lymph node disease (smallest dimension) (the target lesion) within 26 weeks of enrolment. 3. Histologically confirmed diagnosis of neuroendocrine tumor. 4. Progressive disease documented by anatomic imaging and/or presence of new lesions on somatostatin receptor imaging assessed by comparable studies. In the opinion of the investigator, patients with no progression on imaging may still be considered eligible in presence of carcinoid symptoms refractory to treatment with somatostatin receptor analogues. 5. 18F-FDG PET/CT whole-body imaging within 26 weeks of enrolment. 6. Life expectancy greater than 12 weeks from enrollment. 7. Serum creatinine ≤ 150 µmol/L, and a calculated (Cockcroft-Gault) or estimated GFR of ≥ 50 mL/min measured within 2 weeks of enrollment. 8. Haemoglobin concentration ≥ 90 g/L; white blood cell (WBC) count ≥ 2 x 10^9/L; platelets ≥ 100 x 10^9/L measured within 2 weeks of enrolment. 9. Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g/L within 2 weeks of enrolment. 10. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment. 11. Provide written informed consent prior to enrolment. Group B (Maintenance Therapy) Inclusion Criteria: 1. Male or female ≥ 14
  • 90 years of age. 2. Have previously received Lu-DOTA-TATE treatment under the SAP. 3. Life expectancy greater than 12 weeks from enrolment. 4. Serum creatinine ≤ 150 μmol/L, and a calculated (Cockcroft-Gault) or estimated glomerular filtration rate (GFR) of ≥ 50 mL/min measured within 2 weeks of enrolment. 5. Haemoglobin concentration ≥ 90 g/L; white blood cell (WBC) count ≥ 2 x 10^9/L; platelets ≥ 100 x 10^9/L measured within 2 weeks of enrolment. 6. Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g/L within 2 weeks of enrolment. 7. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment. 8. Provide written informed consent prior to enrolment. Group A (Primary Therapy) Exclusion Criteria: 1. Have previously received Lu-DOTA-TATE therapy. 2. Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected. 3. Surgery within 12 weeks of enrolment. Surgery for removal of superficial skin lesions, laser eye surgery, or cataract surgery is permitted. 4. Liver embolization [transcatheter arterial embolization (TAE), TACE, or TARE] within 4 weeks of enrolment. 5. Radioisotope therapy within 12 weeks of enrolment. 6. Systemic therapy: mTOR inhibitors and tyrosine kinase inhibitors within 6 weeks of enrolment; chemotherapy and interferon within 8 weeks of enrolment. 7. Change in long acting somatostatin analogues, dosage, or dosage frequency within 12 weeks of enrolment. 8. Localized external beam irradiation with target lesion(s) in the radiation field. Other localized external beam therapy is permitted. 9. Known brain metastases unless these metastases have been treated and stabilized (confirmed by CT) for ≥ 4 months prior to enrolment 10. Uncontrolled diabetes mellitus defined as random glucose ≥ 2X the upper limit of normal (or HbA1c > 10%, if results available) within 12 weeks of enrolment. 11. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies). 12. Pregnancy. 13. Breast feeding. 14. Prior radiation therapy to more than 25% of the bone marrow. 15. If, in the opinion of the investigator, other treatments are considered more appropriate than the investigational therapy, based on patient and disease characteristics. Group B (Maintenance Therapy)

Exclusion Criteria:

  1. Have previously received Lu-DOTA-TATE therapy.
  2. Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.
  3. Surgery within 12 weeks of enrolment. Surgery for removal of superficial skin lesions, laser eye surgery, or cataract surgery is permitted.
  4. Liver embolization [transcatheter arterial embolization (TAE), TACE, or TARE] within 4 weeks of enrolment.
  5. Radioisotope therapy within 12 weeks of enrolment.
  6. Systemic therapy: mTOR inhibitors and tyrosine kinase inhibitors within 6 weeks of enrolment; chemotherapy and interferon within 8 weeks of enrolment.
  7. Change in long acting somatostatin analogues, dosage, or dosage frequency within 12 weeks of enrolment.
  8. Localized external beam irradiation with target lesion(s) in the radiation field. Other localized external beam therapy is permitted.
  9. Known brain metastases unless these metastases have been treated and stabilized (confirmed by CT) for ≥ 4 months prior to enrolment
  10. Uncontrolled diabetes mellitus defined as random glucose ≥ 2X the upper limit of normal (or HbA1c > 10%, if results available) within 12 weeks of enrolment.
  11. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).
  12. Pregnancy.
  13. Breast feeding.
  14. Prior radiation therapy to more than 25% of the bone marrow.
  15. If, in the opinion of the investigator, other treatments are considered more appropriate than the investigational therapy, based on patient and disease characteristics. Group B (Maintenance Therapy) Exclusion Criteria:
  16. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence or co-existing malignancies).
  17. Pregnancy.
  18. Breast feeding.

View trial on ClinicalTrials.gov


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