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GALLIUM NITRATE FOR THE TREATMENT OF MALIGNANT TUMORS, A PHASE I STUDY


Phase 1
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

GALLIUM NITRATE FOR THE TREATMENT OF MALIGNANT TUMORS, A PHASE I STUDY


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Harry T. Whelan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical College of Wisconsin

Authority:

United States: Federal Government

Study ID:

CDR0000063244

NCT ID:

NCT00002543

Start Date:

February 1995

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Neuroblastoma
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • 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
  • Brain Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Nervous System Neoplasms
  • Neuroblastoma
  • Rhabdomyosarcoma
  • Central Nervous System Neoplasms
  • Sarcoma

Name

Location

Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
Medical College of WisconsinMilwaukee, Wisconsin  53226