Gemcitabine, Cisplatin, and Dexamethasone in Treating Pat... | NCT00090909

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

NCT00090909

Sponsor

Jonsson Comprehensive Cancer Center

Status

Completed

Last Update Posted

Jan 8, 2013Estimated

Enrollment

1Actual

Phase

Phase 2

Conditions

Lymphoma

Interventions

cisplatin
dexamethasone
gemcitabine hydrochloride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Mar 2005Actual

Completion Date

Not provided

First Submitted Date

Sep 7, 2004

First Submission Date that Met QC Criteria

Sep 7, 2004

First Posted Date

Sep 8, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2013

Last Update Posted Date

Jan 8, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008223	Lymphoma
D006689	Hodgkin Disease

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Type	Description	Link
UCLA-030402301
LILLY-B9E-US-X394

Name	Type	Description	Arm Group Labels	Other Names
cisplatin	Drug
dexamethasone	Drug
gemcitabine hydrochloride	Drug

ID	Term
D002945	Cisplatin
D003907	Dexamethasone
D000093542	Gemcitabine