Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors
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| ClinicalTrials.gov Identifier: NCT00002543 |
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Recruitment Status :
Completed
First Posted : October 5, 2004
Last Update Posted : July 18, 2013
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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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3 participants |
| Primary Purpose: | Treatment |
| Official Title: | GALLIUM NITRATE FOR THE TREATMENT OF MALIGNANT TUMORS, A PHASE I STUDY |
| Study Start Date : | February 1995 |
| Actual Study Completion Date : | October 2004 |
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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
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 ClinicalTrials.gov identifier (NCT number): NCT00002543
| 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 | |
| Study Chair: | Harry T. Whelan, MD | Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00002543 |
| Other Study ID Numbers: |
MCW-ARRC-22393 CDR0000063244 ( Registry Identifier: PDQ (Physician Data Query) ) CHW-93/59 NCI-T93-0097D |
| First Posted: | October 5, 2004 Key Record Dates |
| Last Update Posted: | July 18, 2013 |
| Last Verified: | May 2007 |
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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 |
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Lymphoma Neoplasms Neuroblastoma Rhabdomyosarcoma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Sarcoma 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 Myosarcoma Neoplasms, Muscle Tissue Neoplasms by Site Nervous System Diseases Gallium nitrate Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antineoplastic Agents |