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Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002543
Recruitment Status : Completed
First Posted : October 5, 2004
Last Update Posted : July 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Lymphoma Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific Drug: gallium nitrate Phase 1

Detailed Description:

OBJECTIVES: I. Determine the safety and side effects of gallium nitrate (GAN) when used as an anticancer agent in pediatric patients with refractory solid tumors, including malignant brain tumors, neuroblastoma, rhabdomyosarcoma, and non-Hodgkin's lymphoma. II. Evaluate these side effects in these patients.

OUTLINE: Single-Agent Chemotherapy. Gallium Nitrate, GAN, NSC-15200.

PROJECTED ACCRUAL: At least 3 patients will be accrued at each dose studied.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Primary Purpose: Treatment
Study Start Date : February 1995
Actual Study Completion Date : October 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Biopsy-proven rhabdomyosarcoma, non-Hodgkin's lymphoma, or other solid tumor refractory to conventional therapy or for which no effective curative therapy is known Re-biopsy required if disease recurs more than 2 years after initial diagnosis recommended if radiographic abnormalities suggest tumor recurrence within 5 months of completing radiotherapy or chemotherapy

PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: Karnofsky 50%-100% Life expectancy: More than 4 weeks Hematopoietic: (unless extensive bone marrow involvement) ANC greater than 750 Platelets greater than 75,000 Hepatic: Not specified Renal: Creatinine normal for age OR Glomerular filtration rate at least 50 mL/min per 1.73 square meters Other: Adequate nutritional status No serious uncontrolled infection No pregnant or nursing women

PRIOR CONCURRENT THERAPY: At least 2 weeks since other anticancer therapy and recovered Prior radiotherapy or surgery for symptomatic lesions allowed provided site of evaluable disease remains untreated Prior bone marrow or stem cell transplantation allowed No concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002543

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United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States, 02111
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
National Cancer Institute (NCI)
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Study Chair: Harry T. Whelan, MD Medical College of Wisconsin
Layout table for additonal information Identifier: NCT00002543    
Other Study ID Numbers: MCW-ARRC-22393
CDR0000063244 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 5, 2004    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: May 2007
Keywords provided by National Cancer Institute (NCI):
recurrent childhood rhabdomyosarcoma
recurrent childhood brain tumor
recurrent neuroblastoma
recurrent childhood lymphoblastic lymphoma
unspecified childhood solid tumor, protocol specific
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Muscle Tissue
Neoplasms by Site
Nervous System Diseases
Gallium nitrate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antineoplastic Agents