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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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