A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma


OBJECTIVES:

- Determine the response rate and maximum response in patients with relapsed or
refractory Hodgkin's lymphoma treated with gemcitabine, cisplatin, and dexamethasone.

- Determine time to progression in patients treated with this regimen who are not
undergoing stem cell transplantation.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gemcitabine IV over 1 hour on days 1 and 8, cisplatin IV over 3 hours on
day 1, and oral dexamethasone twice daily on days 1-4. Treatment repeats every 21 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed until disease progression.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of Hodgkin's lymphoma

- Measurable disease by radiological or clinical findings

- Failed at least 1, but no more than 2, prior standard chemotherapy regimens

- High-dose chemotherapy administered after a chemotherapy course is considered 2
courses

- No evidence of CNS disease

- No history of myelodysplastic syndromes

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC > 2,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 75,000/mm^3

- Hemoglobin > 8.0 g/dL

Hepatic

- Bilirubin < 2 times upper limit of normal (ULN)

- AST and ALT < 5 times ULN

Renal

- Creatinine < 1.5 times ULN

Other

- Not pregnant or nursing

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No prior gemcitabine

- More than 6 months since prior high-dose chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000380845

NCT ID:

NCT00090909

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781