Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Molgramostim

Sargramostim

Immunologic Factors

Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.

Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.

sargramostim

sentinel lymph node biopsy

laboratory biomarker analysis

hypertonic saline

Richard Essner

This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether sargramostim is more effective than hypertonic saline in treating patients with stage IB-II melanoma undergoing sentinel lymph node biopsy.

PRIMARY OBJECTIVES:

I. To determine if the alterations in morphology and phenotype to the sentinel lymph nodes are reversible.

II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes results in diminished regional tumor burden.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing sentinel lymph node biopsy.

ARM II: Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.

After completion of study treatment, patients are followed up for 30 days.

Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma

Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection

A series of analysis of variance (ANOVA) models will be employed.

The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run.

Genzyme, a Sanofi Company

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Disease Attributes

Carcinoma

Neoplasms, Glandular and Epithelial

40ml of hypersal saline (3% NaCl) will be administered to bladder the after the surgery

40ml of normal saline (0.9% NaCl) will be administered to bladder the after the surgery

Hypertonic Saline

Rina Labiner, MSc

Purpose: to demonstrate a 10% recurrence risk reduction for patients treated with Hypersal versus normal saline immediately following TURBT.

Design: prospective randomized double-blind placebo controlled trial. Outline: eligible patients with non-muscle invasive bladder cancer who undergo TURBT at our center will be randomized to receive either 40ml of normal saline or 40 ml of hypersal intravesically. The primary endpoint is tumor recurrence rate. Secondary endpoint are time to recurrence and side effects.

Patients A total of 150 patients will be enrolled in this trial.

Non-muscle invasive bladder cancer is associated with a high recurrence rate. As a result, clinical guidelines mandate prophylactic treatment in all patients who experience tumor recurrence after the initial resection. This is in contrast to newly diagnosed patients in whom prophylactic intravesical treatment is usually not required. Intravesical prophylaxis consists of weekly intravesical administration of either bacillus Calemtte-Guerin of cytotoxic agents including mitomycin C. This is referred to as induction of therapy followed by various maintenance protocols for periods between 6 months and 3 years duration. These recommendations stand in addition to a single perioperative dose of chemotherapy which is the subject of our research. Consequently, the observed risk reduction for a given patient receiving both a solitary perioperative dose of chemotherapy and additional doses thereafter is the combination of both regimens. To avoid possible bias from induction and maintenance therapy, we decided to include in this phase II trial only newly diagnosed patients with small, superficial-looking tumors who would receive only immediate post resection chemotherapy and would not require subsequent chemotherapy treatment.

Intervention drugs Two NaCl in sterile distilled water solutions will be used. Normal saline comes at a 0.9% concertation as opposed to hypersal with a 3% concertation volume by volume. Both solutions are colorless fluids and both will come as 40ml doses in pre-loaded syringes. All instillation syringes will be coded and the key will be kept concealed by our study coordinator assuring complete double blinding.

Intervention All included patients will undergo a routine TURBT. The number, greatest diameter and site of intravesical tumors will be recorded. Upon documented complete resection blood samples for serum sodium will be drawn from all patients . Participants will then receive a 40 ml intravesical instillation of either Hypersal or normal saline and the catheter will be plugged for 60-90 minutes. After that the catheter will be opened and allowed to drain into a urine bag and blood samples for sodium will be taken again. Patient symptoms and postoperative complications will be recorded using the same instruments used in the previous Phase I trial.

Randomization Patients will be randomized on a 1:1 basis to receive either intravesical solution using a table of random numbers between 0-1.0. All patients with an allocated number \<0.5 will receive normal saline whereas all with a number of 0.5-1.0 will receive hypersal. Treatment allocations will be determined by the study coordinator before the TURBT and analyses of endpoints will be based on intention to treat.

The Aim of This Study is to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer

Randomized Controlled Double-blind Phase II Study to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer

All patients will be followed for one year after recruitment. During this one year period patients will undergo surveillance cystoscopy at 3 months, 6 months and 1 year following enrollment. Time to recurrence will be defined as the number of days from TURBT to recurrence at follow up cystoscopy.

Kaplan Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma	NCT01826864	Stage IB Melano... Stage IIA Melan... Stage IIB Melan... Stage IIC Melan...	sargramostim sentinel lymph ... laboratory biom... hypertonic sali...	18 Years - 75 Years	Jonsson Comprehensive Cancer Center
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma	NCT01826864	Stage IB Melano... Stage IIA Melan... Stage IIB Melan... Stage IIC Melan...	sargramostim sentinel lymph ... laboratory biom... hypertonic sali...	18 Years - 75 Years	Jonsson Comprehensive Cancer Center
The Aim of This Study is to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer	NCT04671407	TCC	Hypertonic Sali...	18 Years - 99 Years	Kaplan Medical Center

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