Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00006102




Registration number
NCT00006102
Ethics application status
Date submitted
3/08/2000
Date registered
27/01/2003
Date last updated
5/02/2013

Titles & IDs
Public title
Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
Scientific title
A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors
Secondary ID [1] 0 0
COG-P9963
Secondary ID [2] 0 0
NCI-2012-01851
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 0 0
Lymphoma 0 0
Neuroblastoma 0 0
Retinoblastoma 0 0
Sarcoma 0 0
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain
Cancer 0 0 0 0
Head and neck
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6006 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Connecticut
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Delaware
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Florida
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Georgia
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Illinois
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Louisiana
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Maine
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New Mexico
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New York
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Groningen
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Auckland
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Bern
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Geneva
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Switzerland
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Lausanne

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne-Marie Langevin, MD
Address 0 0
The University of Texas Health Science Center at San Antonio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Langevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00006102