A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors
18 Years
N/A
Both
Brain and Central Nervous System Tumors, Childhood Langerhans Cell Histiocytosis, Gastrointestinal Carcinoid Tumor, Head and Neck Cancer, Intraocular Melanoma, Islet Cell Tumor, Kidney Cancer, Lung Cancer, Melanoma (Skin), Neoplastic Syndrome, Neuroendocrine Carcinoma of the Skin, Pheochromocytoma
Trial Information
A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors
OBJECTIVES: I. Determine the maximum tolerated dose (MTD), toxic effects, and the
preliminary antitumor activity of indium In 111 pentetreotide.
OUTLINE: This is a dose escalation study. Patients receive indium In III pentetreotide
(OctreoScan) IV on day 1. Imaging is conducted on days 3 and 6. Treatment continues weekly
for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 3 patients receive escalating doses of OctreoScan until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 patients experience dose limiting toxicities. Patients are followed every 3 months for
the first year, then every 6 months thereafter.
PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven malignancy with no alternate treatments
available Measurable or evaluable progressive disease Somatostatin receptors present on
tumor and uptake demonstrated on diagnostic scan with OctreoScan
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil
count at least 1,500/mm3 Hepatic: Total bilirubin no greater than 2.0 mg/dL Renal:
Creatinine clearance at least 40 mL/min Other: No active infections Not HIV positive No
coexisting medical condition Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Not
specified Radiotherapy: At least 4 weeks since prior wide field radiation therapy Surgery:
Recovery from prior surgery
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
John R. Murren, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Yale University
Authority:
United States: Federal Government
Study ID:
CDR0000065414
NCT ID:
NCT00002947
Start Date:
October 1996
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- Childhood Langerhans Cell Histiocytosis
- Gastrointestinal Carcinoid Tumor
- Head and Neck Cancer
- Intraocular Melanoma
- Islet Cell Tumor
- Kidney Cancer
- Lung Cancer
- Melanoma (Skin)
- Neoplastic Syndrome
- Neuroendocrine Carcinoma of the Skin
- Pheochromocytoma
- stage IV renal cell cancer
- recurrent renal cell cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- metastatic gastrointestinal carcinoid tumor
- recurrent gastrointestinal carcinoid tumor
- gastrinoma
- insulinoma
- recurrent islet cell carcinoma
- thyroid gland medullary carcinoma
- prolactin-producing pituitary tumor
- iris melanoma
- ciliary body and choroid melanoma, medium/large size
- extraocular extension melanoma
- recurrent intraocular melanoma
- stage IV melanoma
- recurrent melanoma
- WDHA syndrome
- somatostatinoma
- pancreatic polypeptide tumor
- glucagonoma
- childhood Langerhans cell histiocytosis
- metastatic pheochromocytoma
- recurrent pheochromocytoma
- pulmonary carcinoid tumor
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage III neuroendocrine carcinoma of the skin
- recurrent neuroendocrine carcinoma of the skin
- Neoplasms
- Carcinoid Tumor
- Carcinoma
- Carcinoma, Merkel Cell
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Head and Neck Neoplasms
- Histiocytosis
- Histiocytosis, Langerhans-Cell
- Lung Neoplasms
- Melanoma
- Nervous System Neoplasms
- Pheochromocytoma
- Central Nervous System Neoplasms
- Carcinoma, Neuroendocrine
- Malignant Carcinoid Syndrome
- Gastrointestinal Neoplasms
- Uveal Neoplasms
- Adenoma, Islet Cell
- Skin Neoplasms
- Carcinoma, Basal Cell
- Carcinoma, Basosquamous
- Carcinoma, Squamous Cell
Name | Location |
|---|---|
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
