A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed Hodgkin's lymphoma* with any of the following histologies:

- Not otherwise specified (NOS)

- Mixed cellularity NOS

- Lymphocytic depletion

- NOS

- Diffuse fibrosis

- Reticular

- Lymphocytic predominance

- NOS

- Diffuse

- Nodular

- Paragranuloma

- Granuloma

- Sarcoma

- Nodular sclerosis

- Cellular phase

- NOS

- Lymphocytic predominance

- Mixed cellularity

- Lymphocytic depletion NOTE: *Disease metastatic to bone marrow with
granulocytopenia and/or thrombocytopenia is allowed, but is not evaluable
for hematological toxicity

- Measurable disease by clinical or radiographic criteria

- Relapsed or refractory to conventional therapy

- Received at least 2 prior cytotoxic chemotherapy regimens

- No stage IA or IIA nodal disease previously treated with any of the following:

- Radiotherapy only

- No more than 4 courses of prior chemotherapy

PATIENT CHARACTERISTICS:

Age

- 30 and under

Performance status

- Karnofsky 50-100% (over 16 years of age)

- Lansky 50-100% (16 and under) OR

- ECOG 0-2

Life expectancy

- At least 8 weeks

Hematopoietic

- See Disease Characteristics

- Absolute neutrophil count ≥ 750/mm^3

- Platelet count ≥ 75,000/mm^3 (transfusion independent, defined as ≥ 3 days since
prior platelet transfusion)

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT ≤ 2.5 times ULN

Renal

- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR

- Creatinine based on age as follows:

- No greater than 0.8 mg/dL (age 5 and under)

- No greater than 1.0 mg/dL (age 6 to 10)

- No greater than 1.2 mg/dL (age 11 to 15)

- No greater than 1.5 mg/dL (over age 15)

Pulmonary

- DLCO ≥ 50%

- FEV_1 ≥ 50%

- Vital capacity ≥ 50%

- No evidence of dyspnea at rest

- No exercise intolerance

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- Seizure disorder allowed provided patient is on anticonvulsants and disorder is well
controlled

- No evidence of active graft-versus-host disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Recovered from prior immunotherapy

- At least 6 months since prior allogeneic stem cell transplantation (SCT)

- At least 7 days since prior biologic agents

- More than 3 months since prior autologous SCT

- More than 1 week since prior growth factors

- No concurrent immunomodulating agents

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)

- Prior gemcitabine or vinorelbine administered alone is allowed

- 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:

- Adrenal crisis in patients with suppressed pituitary/adrenal response

- Noncardiogenic pulmonary edema

- Allergic reactions to amphotericin or transfusions treated with low-dose
hydrocortisone (less than 100 mg/m^2)

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery

- Not specified

Other

- Concurrent immunosuppressive drugs allowed