Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
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Purpose
Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Lymphoma Neuroblastoma Retinoblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: becatecarin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors |
| Enrollment: | 200 |
| Study Start Date: | July 2000 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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. |
Drug: becatecarin |
Detailed Description:
OBJECTIVES:
I. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue.
II. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients.
III. Determine the toxicity of this drug in these patients. IV. 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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Show 226 Study Locations| Study Chair: | Anne-Marie Langevin, MD | University of Texas Health Science Center at San Antonio |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006102 History of Changes |
| Other Study ID Numbers: | NCI-2012-01851, COG-P9963, CDR0000068111 |
| Study First Received: | August 3, 2000 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 May 23, 2013