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

Phase 2
21 Years
Not Enrolling
Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma, Retinoblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

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


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

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

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

Inclusion Criteria


- 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



- 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


- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 75,000/mm^3

- Hemoglobin greater than 8.0 g/dL


- Bilirubin normal for age

- SGPT less than 2.5 times upper limit of normal

- Amylase normal

- Lipase normal


- Creatinine normal for age OR

- Glomerular filtration rate at least 60 mL/min


- No concurrent uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study


Biologic therapy:

- Recovered from prior immunotherapy


- 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


- At least 6 weeks since prior extended radiotherapy and recovered

- No prior total body irradiation


- Prior radiosurgery allowed


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Anne-Marie Langevin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio


United States: Food and Drug Administration

Study ID:




Start Date:

July 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Neuroblastoma
  • Retinoblastoma
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Nervous System Neoplasms
  • Neuroblastoma
  • Retinoblastoma
  • Central Nervous System Neoplasms
  • Neoplasms
  • Sarcoma



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Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
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Sioux Valley Hospital Sioux Falls, South Dakota  57117
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Methodist Health Care System San Antonio, Texas  78229-3902
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