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Ganite (Gallium Nitrate) - Summary



Concurrent use of gallium nitrate with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin B) may increase the risk for developing severe renal insufficiency in patients with cancer-related hypercalcemia. If use of a potentially nephrotoxic drug is indicated during gallium nitrate therapy, gallium nitrate administration should be discontinued and it is recommended that hydration be continued for several days after administration of the potentially nephrotoxic drug. Serum creatinine and urine output should be closely monitored during and subsequent to this period. Ganite therapy should be discontinued if the serum creatinine level exceeds 2.5 mg/dL.



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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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.

Antimicrobial activity of gallium nitrate against Mycobacterium avium subsp. paratuberculosis in neonatal calves. [2011.09]
BACKGROUND: Mycobacterium avium subsp... CONCLUSIONS AND CLINICAL RELEVANCE: Chemoprophylactic treatment of calves with Ga before and during the period of high susceptibility decreased MAP tissue colonization in experimentally infected neonatal calves.

Hepatocellular carcinoma detection by gallium scan and subsequent treatment by gallium maltolate: rationale and case study. [2011.07]
Gallium is antiproliferative to many types of cancer, due primarily to its ability to act as a non-functional mimic of ferric iron (Fe(3+)).At eight weeks, CT scans showed apparent necrosis of the tumor.

Comparison of the therapeutic effects of yeast-incorporated gallium with those of inorganic gallium on ovariectomized osteopenic rats. [2010.06]
The purpose of this study was to compare the effect and toxicity of yeast-incorporated gallium (YG) with inorganic gallium (gallium nitrate, IG) in preventing osteoporosis in ovariectomized (OVX) Wistar female rats. After the rats were treated orally with YG and IG respectively, the urine calcium, plasma calcium, plasma phosphorus, bone mineral content, mechanical testing, and the mass of uterus, thymus, and body were examined.

Medical applications and toxicities of gallium compounds. [2010.05]
Over the past two to three decades, gallium compounds have gained importance in the fields of medicine and electronics.This review will discuss the medical applications of gallium and its mechanisms of action, the newer gallium compounds and future directions for development, and the toxicities of gallium compounds in current use.

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Clinical Trials Related to Ganite (Gallium Nitrate)

A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients [Active, not recruiting]
The purpose of this research study is to test the pharmacokinetics, safety, and tolerability of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the drug are found in the sputum.

Funding Source - FDA OOPD

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.

Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE) Followed by Gallium Nitrate, Rituximab and Dexamethasone (GARD) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma [Terminated]
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.

A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study) [Not yet recruiting]

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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Page last updated: 2011-12-09

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