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

Phase 2
30 Years
Not Enrolling

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Trial Information

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


- Determine the response rate of pediatric patients with recurrent or refractory
Hodgkin's lymphoma treated with gemcitabine and vinorelbine.

- Determine the toxicity of this regimen in these patients.

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

Inclusion Criteria


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

- Not otherwise specified (NOS)

- Mixed cellularity NOS

- Lymphocytic depletion


- Diffuse fibrosis

- Reticular

- Lymphocytic predominance


- Diffuse

- Nodular

- Paragranuloma

- Granuloma

- Sarcoma

- Nodular sclerosis

- Cellular phase


- 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



- 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


- 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)


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

- ALT ≤ 2.5 times ULN


- 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)


- DLCO ≥ 50%

- FEV_1 ≥ 50%

- Vital capacity ≥ 50%

- No evidence of dyspnea at rest

- No exercise intolerance


- Not pregnant or nursing

- Negative pregnancy test

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

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

- No evidence of active graft-versus-host disease


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


- 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)


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered


- Not specified


- Concurrent immunosuppressive drugs allowed

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Toxic death, Hepatic, cardiac or renal toxicity, Hematologic toxicity, pulmonary toxicity or other grade 3 or 4 toxicities from interventions.

Outcome Time Frame:

Up to 4 years.

Safety Issue:


Principal Investigator

Peter Cole, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • childhood lymphocyte predominant Hodgkin lymphoma
  • childhood lymphocyte depletion Hodgkin lymphoma
  • childhood nodular sclerosis Hodgkin lymphoma
  • childhood mixed cellularity Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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