Gemcitabine, Cisplatin, and Dexamethasone in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

cisplatin

dexamethasone

gemcitabine hydrochloride

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Jonsson Comprehensive Cancer Center at UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00090909

First Posted

September 7, 2004

Last Updated

January 7, 2013

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00090909

Brief Title

Gemcitabine, Cisplatin, and Dexamethasone in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

March 2005 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and dexamethasone, work in 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 and cisplatin together with dexamethasone works in treating patients with relapsed or refractory Hodgkin's lymphoma.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christos E. Emmanouilides, MD

Organizational Affiliation

Jonsson Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Jonsson Comprehensive Cancer Center at UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1678

Country

United States

Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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