Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

NCT01606072 | Completed Phase 2

• 1 other identifier: DDAVP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The propose for this study is to evaluate the safety and tolerability of desmopressin when administered perioperatively to patients with breast cancer undergoing surgery as first treatment, and select the optimum dose for the clinical development of the product.

Conditions

Breast Cancer

Keywords

DDAVP

Outcome Measures

Primary Outcomes (1)

• Selection of the higher safe dose level for ensuing clinical trials

  One of the three dose levels assessed in this study will be selected for further clinical testing in adults: 0,50 mg, 1,0 mg, 1,25 mg, 1,5 mg or 2,0 mg.

  Up to 2 years

Secondary Outcomes (16)

• Evidence of V2 Receptor Expression

  Baseline

• Evidence of CTC (CIRCULATING TUMOR CELLS)

  Baseline

• Evidence of Von Willebrand factor antigen (VWF:Ag)

  Baseline

• Evidence of CTC (circulating tumor cells)

  30 minutes pre surgery and 24 hours post the surgery

• Evidence of CTC (circulating tumor cells)

  2 Weeks

Study Arms (1)

Desmopressin

EXPERIMENTAL

Drug: Desmopressin

Interventions

Desmopressin DRUG

20 patients in 5 groups 4 each, advancing progressively to each dose level.

Desmopressin

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• a. Female subjects from 21 to 60 years of age, who have voluntarily signed the informed consent form.
• c. Candidate for radical mastectomy and requiring resection of axillary lymph nodes or sentinel node.
• d. In case of women of childbearing potential, an adequate birth control method (intrauterine device, barrier methods, or tubal ligation) should be used throughout the study. Post-menopausal women should have menopause confirmed by biochemical parameters.
• e. Adequate organic function, defined by the following parameters:
• Electrocardiogram (ECG) with no significant anomalies, performed within 14 days prior to surgery.
• The following laboratory results, obtained 7 days before surgery:
• Hemoglobin ≥ 11 g/dL
• Total white blood cell count ≥ 4,000/mm3
• Total neutrophil count 1,500/mm3
• Platelet count within normal limits
• Total bilirubin ≤1.5 x UNL or 2.5 x UNL in case of hepatic metastasis
• Transaminases ALT/GPT and AST/GOT ≤ 1.5 x UNL
• Creatinine clearance \>50 mg/dL
• CT scan with oral and endovenous contrast\* of chest, pelvis, and abdomen, and bone scan, conducted within 28 days prior to surgery. Images taken not longer than 90 days before surgery are also acceptable.
• In case contrast is contraindicated, CT with no contrast or MRI will be performed.

You may not qualify if:

• a. Synchronic bilateral breast cancer. b. Symptoms of metastasis or evidence of metastasis from images: chest spiral CT scan, abdomen/pelvis spiral CT scan, brain spiral CT/MRI (in case of brain metastasis signs), and bone scan.
• c. The patient is pregnant or breastfeeding. d. The patient is presently using hormonal contraceptives or under hormonal treatment. She would be eligible if oral contraceptives were discontinued or if the hormonal treatment finished 30 days before surgery and the patient agreed to use another contraceptive method.
• e. Patients with a history or presence of congestive heart failure, blood hypertension, angina pectoris or heart arrhythmia, thromboembolic disease, diabetes type I or II, or any underlying coronaropathy detected in pre-surgical evaluations.
• f. Mentally-impaired patients. g. Patients with known hypersensitivity to DDAVP or vasopressin, o with severe von Willebrand's disease (VWD), defined by a VWF activity \<10%IU/dL, or type 2B VWD, defined by an increased ristocetin-induced platelet aggregation (RIPA) at low concentrations of ristocetin or with hemophilia.
• h. Patients with a history of seizures. i. Patients with renal impairment (creatinine clearance \< 50 mL/min calculated by the Cockcroft-Gault formula), hyponatremia or with a history of hyponatremia.
• j. Patients with syndrome of inadequate secretion of antidiuretic hormone. k. Patients with positive serology for the hepatitis B or C virus and/or HIV. l. Patients with known hepatic disease (diagnosed cirrhosis, hepatic enzymes (GOT/GPT) \> 1.5 x UNL, Total bilirubin \> 1.5 x UNL).
• m. Patients with active infections. n. Patients with other malignant diseases, with the exception of, non-melanoma skin cancer, or cervix cancer in situ, or any other tumor that has received adequate treatment and shows a disease-free time ≥ 5 years.
• o. Patients participating in another clinical study or cases in which less than 4 weeks have elapsed since participation in another clinical study.

Sponsors & Collaborators

• Laboratorio Elea Phoenix S.A.: lead

Study Sites (1)

Hospital Interzonal General De Agudos EvaPeron

Buenos Aires, Buenos Aires, Argentina

Location

Related Publications (1)

• Weinberg RS, Grecco MO, Ferro GS, Seigelshifer DJ, Perroni NV, Terrier FJ, Sanchez-Luceros A, Maronna E, Sanchez-Marull R, Frahm I, Guthmann MD, Di Leo D, Spitzer E, Ciccia GN, Garona J, Pifano M, Torbidoni AV, Gomez DE, Ripoll GV, Gomez RE, Demarco IA, Alonso DF. A phase II dose-escalation trial of perioperative desmopressin (1-desamino-8-d-arginine vasopressin) in breast cancer patients. Springerplus. 2015 Aug 19;4:428. doi: 10.1186/s40064-015-1217-y. eCollection 2015.

  PMID: 26306290 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Dra. Ruth Weinberg

  Hospital Interzonal General De Agudos Eva Peron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 25, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

AR (1)