A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease
A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 1.5 years.
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma* with any of the following histologies:
Not otherwise specified (NOS)
Mixed cellularity NOS
Lymphocytic depletion
Lymphocytic predominance
Paragranuloma
Granuloma
Sarcoma
Nodular sclerosis
Measurable disease by clinical or radiographic criteria
Relapsed or refractory to conventional therapy
No stage IA or IIA nodal disease previously treated with any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
Creatinine based on age as follows:
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
See Disease Characteristics
More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
No prior gemcitabine and vinorelbine in combination (i.e., administered within 1 week of each other)
No other concurrent chemotherapy
Endocrine therapy
No concurrent steroids, including corticosteroids as an antiemetic or for control of graft-versus-host disease
Concurrent corticosteroids allowed only for the following indications:
Radiotherapy
Surgery
Other
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