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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: GALLIUM NITRATE FOR THE TREATMENT OF MALIGNANT TUMORS, A PHASE I STUDY

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 3
Study Start Date: February 1995
Study Completion Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002543

Locations
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
Investigators
Study Chair: Harry T. Whelan, MD Medical College of Wisconsin
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002543     History of Changes
Other Study ID Numbers: MCW-ARRC-22393, CDR0000063244, CHW-93/59, NCI-T93-0097D
Study First Received: November 1, 1999
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

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:
Neuroblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Rhabdomyosarcoma
Lymphoma
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gallium nitrate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014