Ganite (Gallium Nitrate) - Summary

GANITE SUMMARY

Gallium nitrate injection is a clear, colorless, odorless, sterile solution of gallium nitrate, a hydrated nitrate salt of the group IIIa element, gallium. Gallium nitrate is formed by the reaction of elemental gallium with nitric acid, followed by crystallization of the drug from the solution. The stable, nonahydrate, Ga(N0₃)3•9H₂O is a white, slightly hygroscopic, crystalline powder of molecular weight 417.87, that is readily soluble in water. Each mL of Ganite (gallium nitrate injection) contains gallium nitrate 25 mg (on an anhydrous basis) and sodium citrate dihydrate 28.75 mg. The solution may contain sodium hydroxide or hydrochloric acid for pH adjustment to 6.0-7.0.

Ganite is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. In general, patients with a serum calcium (corrected for albumin) < 12 mg/dL would not be expected to be symptomatic. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). In the treatment of cancer-related hypercalcemia, it is important first to establish adequate hydration, preferably with intravenous saline, in order to increase the renal excretion of calcium and correct dehydration caused by hypercalcemia.

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NEWS HIGHLIGHTS

Published Studies Related to Ganite (Gallium Nitrate)

Randomized, double-blind, phase II trial of gallium nitrate compared with pamidronate for acute control of cancer-related hypercalcemia. [2006.01]
BACKGROUND: Both gallium nitrate and pamidronate are highly effective for acute control of cancer-related hypercalcemia. However, the proportion of patients who actually achieve normocalcemia has varied in published reports... Results from this trial suggest that gallium nitrate may be particularly useful in patients with epidermoid cancers or severe hypercalcemia at baseline, and in patients who have previously exhibited a poor response to bisphosphonates.

Gallium maltolate treatment eradicates Pseudomonas aeruginosa infection in thermally injured mice. [2009.04]
Gallium (Ga) is a semimetallic element that has demonstrated therapeutic and diagnostic-imaging potential in a number of disease settings, including cancer and infectious diseases. Gallium's biological actions stem from its ionic radius being almost the same as that of ferric iron (Fe(3+)), whereby it can replace iron (Fe) in Fe(3+)-dependent biological systems, such as bacterial and mammalian Fe transporters and Fe(3+)-containing enzymes...

Microscopic investigation of the use of gallium nitrate for root surface treatment in rat teeth submitted to delayed replantation. [2007]
The aim of this study was to investigate the effect of gallium nitrate solution, an anti-resorption substance, when applied for root surface treatment in rat teeth submitted to delayed replantation, in order to inhibit the root resorption process and enhance repair...

Effect of gallium nitrate on tamoxifen induced hypercalcemia in rats bearing mammary tumor. [2006.06]
AIM: To study the effect of gallium nitrate in the treatment of flare hypercalcemia in rats, bearing mammary tumor with bone metastasis... CONCLUSIONS: Administration of gallium nitrate in vivo is highly effective in treatment of flare hypercalcemia.

Antimicrobial activity of gallium against virulent Rhodococcus equiin vitro and in vivo. [2006.04]
Rhodococcus equi, a facultative intracellular bacterium, causes severe pneumonia in foals. Evidence suggests that most foals become infected very early in life, when they have immature or ineffective innate immune responses.

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Clinical Trials Related to Ganite (Gallium Nitrate)

Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma [Completed]
Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day by continuous IV infusion for 7 consecutive days using a portable infusion pump. Hospitalization is not required. Stable or responding patients will receive additional gallium nitrate infusions every 3 weeks until the time of disease progression, for a maximum total of 8 infusions, or 2 cycles after complete remission has been documented.

Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma [Completed]
RATIONALE: Chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gallium nitrate in treating patients with AIDS-related non-Hodgkin's lymphoma.

Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE) Followed by Gallium Nitrate, Rituximab and Dexamethasone (GARD) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma [Recruiting]
The purpose of this study is to find out what effects, good and/or bad; rituximab, ifosfamide, carboplatin and etoposide (RICE) followed by gallium nitrate, rituximab and dexamethasone (GARD) have on diffuse large B cell lymphoma.

This research is being done to try to find a more effective treatment for this type of cancer. We want to know whether treatment with rituximab, ifosfamide, carboplatin and etoposide (RICE) then followed by gallium nitrate, rituximab and dexamethasone (GARD) will improve survival.

Rituximab, ifosfamide, carboplatin and etoposide (RICE) are part of the usual treatment for diffuse large B-cell lymphoma.

Gallium nitrate, rituximab and dexamethasone (GARD) in lymphoma is experimental.

Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors [Completed]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: : Phase I trial to study the effectiveness of gallium nitrate in young patients who have malignant brain tumors, neuroblastoma, rhabdomyosarcoma, non-Hodgkin's lymphoma, or refractory solid tumor.

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