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Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00006368
First received: October 4, 2000
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating patients who have refractory or recurrent cancer.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Breast Cancer
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Lung Cancer
Lymphoma
Melanoma (Skin)
Neoplastic Syndrome
Radiation: yttrium Y 90-edotreotide
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Maximum Tolerated Single-Cycle and Four-Cycle Dose-Finding Study to Evaluation the Safety and Tolerability of 90Y-SMT 487 Administered by Intravenous Infusion to Subjects With Refractory Somatostatin-Receptor Positive Tumors

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 60
Study Start Date: January 1998
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of yttrium Y 90-SMT 487 in patients with recurrent malignant neoplasms that prove positive for somatostatin receptors. II. Determine the safety and lifetime serious adverse event profile of this regimen in these patients. II. Determine the antitumor effect and the effect of repeated administrations on the renal excretion pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients undergo octreotide scintigraphy to determine the location of somatostatin receptors. Patients then receive yttrium Y 90-SMT 487 IV over 15 minutes on day 1. Treatment continues every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are entered on course I (vertical dose escalation) and courses II, III, and IV (horizontal dose escalation). Cohorts receive escalating doses of yttrium Y 90-SMT 487 until the maximum tolerated dose (MTD) is determined. MTDs are determined for a single course and for 4 courses. The MTD is defined as the dose preceding that at which no more than 2 of 6 patients experience dose limiting toxicities. Results of course I determine the dosage of subsequent courses. Patients are evaluated on days 2 and 7, and at weeks 4 and 6, following each injection of yttrium Y 90-SMT 487. Patients are followed at 12 and 18 months and then annually thereafter.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed, progressive malignant neoplasm Clinical diagnosis of multiple endocrine neoplasia (MEN) types I and II allowed Tumors positive for somatostatin receptors by octreotide scintigraphy, such as: Pituitary Brain Endocrine pancreatic Lymphoma Carcinoid Melanoma Small cell lung Breast Disease not amenable to standard treatment OR Failed existing first and second line therapies (failed at least 1 regimen in the case of small cell lung cancer) Bone disease (no diffuse bone marrow involvement), pleural effusions, and ascites allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Course I: Karnofsky 50-100% Courses II-IV: Karnofsky 30-100% Life expectancy: At least 6 months and no greater than 2.5 years (for course I only) Hematopoietic: Course I: Hemoglobin at least 8 g/dL WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Courses II-IV: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No history of congestive heart failure unless ejection fraction at least 40% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No other concurrent malignancy except MEN I or II or squamous cell skin cancer No concurrent significant, uncontrolled, medical, psychiatric, or surgical condition that would preclude study (course 1)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy Greater than 4 weeks since prior chemotherapy Endocrine therapy: At least 4 months since prior long acting somatostatin analogue Concurrent hormonal therapy (except somatostatin analogues) allowed if started at least 2 months previously Radiotherapy: Greater than 4 weeks since prior radiotherapy No prior radiotherapy to at least 25% of bone marrow Surgery: Greater than 4 weeks since prior surgery Other: Greater than 4 weeks since prior investigational drugs No other concurrent investigational drug therapy No other concurrent antineoplastic therapy Concurrent bisphosphonates allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006368

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Larry K. Kvols, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00006368     History of Changes
Other Study ID Numbers: NOVARTIS-SMT-B151, MCC-12275, MCC-IRB-5473, CDR0000068241, NCI-G00-1857
Study First Received: October 4, 2000
Last Updated: April 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Novartis:
stage IV adult Hodgkin lymphoma
stage IV breast cancer
recurrent breast cancer
recurrent non-small cell lung cancer
recurrent adult Hodgkin lymphoma
extensive stage small cell lung cancer
recurrent small cell lung cancer
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
gastrinoma
recurrent adult brain tumor
insulinoma
recurrent islet cell carcinoma
ACTH-producing pituitary tumor
prolactin-producing pituitary tumor
growth hormone-producing pituitary tumor
recurrent pituitary tumor
TSH producing pituitary tumor
nonfunctioning pituitary tumor
adult brain stem glioma
adult craniopharyngioma
adult medulloblastoma
adult meningioma
adult glioblastoma
stage IV melanoma
recurrent melanoma
stage IV non-small cell lung cancer
WDHA syndrome
somatostatinoma
pancreatic polypeptide tumor

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoid Tumor
Central Nervous System Neoplasms
Gastrointestinal Neoplasms
Lung Neoplasms
Lymphoma
Malignant Carcinoid Syndrome
Melanoma
Neoplasms
Nervous System Neoplasms
Syndrome
Adenocarcinoma
Breast Diseases
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Disease
Gastrointestinal Diseases
Immune System Diseases
Immunoproliferative Disorders
Lung Diseases
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Diseases
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 20, 2014