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A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease

Phase 1/Phase 2
Not Enrolling

Thank you

Trial Information

A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease


- Determine the maximum tolerated dose and toxicity of gemcitabine, vinorelbine, and
doxorubicin HCl liposome in patients with relapsed or refractory Hodgkin's lymphoma.

- Determine the complete and partial response rates of patients treated with this

OUTLINE: This is a dose-escalation, multicenter study.

Phase I:

- Patients receive vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and
doxorubicin HCl liposome IV over 30-60 minutes on days 1 and 8. Treatment continues
every 21 days for 2-6 courses in the absence of unacceptable toxicity or disease
progression. Patients who respond to treatment after 2 or more courses may stop
protocol therapy to undergo peripheral blood stem cell transplantation.

Cohorts of 3-6 patients receive escalating doses of vinorelbine, gemcitabine, and
doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to
receive treatment with gemcitabine, vinorelbine, and doxorubicin HCl liposome at the
recommended phase II dose.

Phase II:

- Patients are assigned to 1 of 2 treatment groups.

- Group 1: Patients who have not undergone prior transplantation receive
vinorelbine, gemcitabine, and doxorubicin HCl liposome as in phase I.

- Group 2: Patients who have undergone prior transplantation receive lower doses of
vinorelbine, gemcitabine, and doxorubicin HCl liposome as in group 1.

Patients are followed every 6 months for 2 years and then annually for 6 years.

PROJECTED ACCRUAL: Approximately 3-100 patients (3-42 for phase I and 20-58 for phase II [29
per group]) will be accrued for this study within 3 years.

Inclusion Criteria


- Histologically confirmed Hodgkin's lymphoma that is recurrent or refractory after
standard chemotherapy

- Core biopsy is acceptable if adequate tissue is obtained for primary diagnosis
and immunophenotyping

- Bone marrow biopsy is not acceptable as sole means of diagnosis

- Measurable disease

- Tumor mass greater than 1 cm



- Any age

Performance status:

- Not specified

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2.0 mg/dL unless history of Gilbert's disease

- AST no greater than 2 times upper limit of normal


- Creatinine no greater than 2.0 mg/dL


- LVEF at least 45% by MUGA (for patients whose lifetime cumulative doxorubicin dose
exceeds 400 mg/m^2)


- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- See Disease Characteristics

- See Cardiovascular

- No prior gemcitabine, vinorelbine, or doxorubicin HCl liposome

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormones except for nondisease-related conditions (e.g., insulin for
diabetes) or steroids for adrenal failure

- No concurrent dexamethasone or other steroidal antiemetics


- Not specified


- Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Nancy L. Bartlett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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