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

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Medical College of Wisconsin
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
recurrent childhood rhabdomyosarcoma
recurrent neuroblastoma
recurrent childhood large cell lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood brain tumor
unspecified childhood solid tumor, protocol specific
recurrent childhood lymphoblastic lymphoma
 Drug: gallium nitrate
Phase I

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma;   Neuroblastoma;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Gallium Nitrate in Children with Malignant Brain Tumors, Neuroblastoma, Rhabdomyosarcoma, non-Hodgkin's Lymphoma, and Other Refractory Solid Tumors

Further Study Details: 

Study start: February 1995

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.

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

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

Eligibility

Ages Eligible for Study:  up to  21 Years

Criteria

PROTOCOL ENTRY CRITERIA:

** BRAIN TUMOR PATIENTS **

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: 21 and under
  • Performance status: Lansky 70%-100% (Karnofsky 70%-100% in older patients)
  • Life expectancy: At least 6 weeks
  • Hematopoietic: WBC at least 4,000; Platelets at least 100,000
  • Hepatic: Bilirubin no greater than 1.2 mg/dL
  • Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance greater than 60 mL/min per 1.73 square meters
  • Other: No other uncontrolled malignancy; No pregnant or nursing women

** NON-BRAIN TUMOR PATIENTS **

--Disease Characteristics--

--Prior/Concurrent Therapy--

--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

Location Information


Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

Massachusetts
      Boston Floating Hospital Infants and Children, Boston,  Massachusetts,  02111,  United States

Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States

Study chairs or principal investigators

Harry T. Whelan,  Study Chair,  Medical College of Wisconsin   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000063244; MCW-ARRC-22393; NCI-T93-0097D; CHW-93/59
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002543
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005