Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006102

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Lymphoma Neuroblastoma Retinoblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific	Drug: becatecarin	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma retinoblastoma

MedlinePlus related topics: Cancer Lymphoma Neuroblastoma Soft Tissue Sarcoma

Drug Information available for: BMS 181176

U.S. FDA Resources

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

Study Start Date:	July 2000
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue.
Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients.
Determine the toxicity of this drug in these patients.
Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma [closed to accrual as of 5/19/03]/peripheral primative neuroectodermal tumor [PNET] vs osteosarcoma [closed to accrual as of 5/19/03] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors).

Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100-200 patients will be accrued for this study within 2.4 months to 2.5 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed solid tumors
- Neuroblastoma
- Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's sarcoma closed to accrual as of 5/19/03)
- Osteosarcoma (closed to accrual as of 5/19/03)
- Rhabdomyosarcoma
- Other extracranial solid tumors
- CNS/brain tumors:
  - Medulloblastoma/PNET
  - Ependymoma
  - Brainstem glioma
  - Other CNS tumors
- Histological verification may be waived for brainstem glioma and classic optic glioma, but biopsy recommended OR
Histologically or cytologically proven non-Hodgkin's lymphoma
- Refractory to standard treatment and no curative therapy available
Measurable disease

PATIENT CHARACTERISTICS:

Age:

21 and under at time of original diagnosis

Performance status:

Karnofsky 50-100% in patients over 10 years of age
Lansky 50-100% in patients age 10 and under

Life expectancy:

At least 8 weeks

Hematopoietic:

Absolute neutrophil count greater than 1,000/mm^3
Platelet count greater than 75,000/mm^3
Hemoglobin greater than 8.0 g/dL

Hepatic:

Bilirubin normal for age
SGPT less than 2.5 times upper limit of normal
Amylase normal
Lipase normal

Renal:

Creatinine normal for age OR
Glomerular filtration rate at least 60 mL/min

Other:

No concurrent uncontrolled infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Recovered from prior immunotherapy

Chemotherapy:

At least 6 weeks since prior nitrosourea and recovered
Recovered from any other prior chemotherapy
No more than two prior chemotherapy regimens

Endocrine therapy:

CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at least 2 weeks prior to study entry

Radiotherapy:

At least 6 weeks since prior extended radiotherapy and recovered
No prior total body irradiation

Surgery:

Prior radiosurgery allowed

Other:

No concurrent use of the following foods or medications:
- Grapefruit juice
- Erythromycin
- Azithromycin
- Clarithromycin
- Rifampin and analogues
- Fluconazole
- Ketoconazole
- Itraconazole
- Cimetidine
- Cannabinoids (marijuana or dronabinol)
- Leukotriene inhibitors (e.g., zafirlukast and zileuton)
No other concurrent anticancer or investigational agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006102

Show 226 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Anne-Marie Langevin, MD

University of Texas

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Langevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy P, Sun J, Chen Z, Adamson PC. A phase II trial of rebeccamycin analogue (NSC #655649) in children with solid tumors: A Children's Oncology Group study. Pediatr Blood Cancer. 2007 Jul 3; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00006102 History of Changes
Other Study ID Numbers:	CDR0000068111, COG-P9963
Study First Received:	August 3, 2000
Last Updated:	December 15, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

childhood infratentorial ependymoma
recurrent childhood rhabdomyosarcoma
childhood supratentorial ependymoma
childhood craniopharyngioma
disseminated neuroblastoma
recurrent neuroblastoma
intraocular retinoblastoma
extraocular retinoblastoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
childhood central nervous system germ cell tumor
unspecified childhood solid tumor, protocol specific
childhood high-grade cerebral astrocytoma
childhood oligodendroglioma

childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
stage III childhood large cell lymphoma
stage IV childhood small noncleaved cell lymphoma
stage IV childhood large cell lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
recurrent childhood brain stem glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Nervous System Neoplasms
Neuroblastoma
Retinoblastoma
Central Nervous System Neoplasms
Neoplasms
Sarcoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site

Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Eye Diseases
Retinal Diseases
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on February 12, 2012