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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002543
First received: November 1, 1999
Last updated: July 17, 2013
Last verified: May 2007

November 1, 1999
July 17, 2013
February 1995
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Complete list of historical versions of study NCT00002543 on ClinicalTrials.gov Archive Site
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Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors
GALLIUM NITRATE FOR THE TREATMENT OF MALIGNANT TUMORS, A PHASE I STUDY

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Neuroblastoma
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
Drug: gallium nitrate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
October 2004
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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

Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002543
MCW-ARRC-22393, CDR0000063244, CHW-93/59, NCI-T93-0097D
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Medical College of Wisconsin
National Cancer Institute (NCI)
Study Chair: Harry T. Whelan, MD Medical College of Wisconsin
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP