Clinical trial · Interventional

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

A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors

NCT00006102CI-TRIAL-00009316completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Retinoblastoma	Retinoblastoma	ONTOLOGY_EXACT	0.98
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98
Unspecified Childhood Solid Tumor, Protocol Specific	Childhood Solid Neoplasm	ALIAS	0.85

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
becatecarin	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Arm I
description
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.
interventionNames
1. Drug: becatecarin

Primary outcomes (0)

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Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 21 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTLangevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy P, Sun J, Chen Z, Adamson PC; Children's Oncology Group. A phase II trial of rebeccamycin analogue (NSC #655649) in children with solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 Mar;50(3):577-80. doi: 10.1002/pbc.21274. PMID 17610262

Registry

Dates and enrollment

Start: Jul 1, 2000
Primary completion: Jun 1, 2006
Completion: —
First posted: Jan 27, 2003
Last update posted: Feb 5, 2013
Enrollment: 200 (actual)
Lead sponsor: National Cancer Institute (NCI) NIH
Keywords: 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, previously treated childhood rhabdomyosarcoma, recurrent childhood ependymoma, recurrent retinoblastoma

Data updated 22 days agoSource updated Feb 5, 2013source: clinicaltrials