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Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment

Primary Purpose

Lymphoma

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

rituximab

gemcitabine hydrochloride

vinorelbine ditartrate

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, adult lymphocyte depletion Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma, adult mixed cellularity Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following cell types:
- Nodular sclerosis
- Mixed cellularity
- Lymphocyte-rich
- Lymphocyte-depleted
Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy
No known CNS metastasis

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
ANC > 1,500/mm^3
Platelet count > 75,000/mm^3
Total bilirubin ≤ 2 mg/dL (unless due to hemolysis)
AST or ALT ≤ 2.5 times upper limit of normal
Creatinine normal OR creatinine clearance ≥ 50 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active hepatitis B infection
No known chronic hepatitis B carrier
No HIV positivity
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Symptomatic neurological illness
- Active uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of study treatment
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Significant pulmonary disease or hypoxia
- Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 14 days since prior chemotherapy, immunotherapy, biological therapy, or investigational therapy and recovered
No prior gemcitabine hydrochloride, vinorelbine ditartrate, or rituximab
No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy

Sites / Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1 (eligible for SCT)

Group 2 (ineligible for SCT)

Arm Description

Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.

Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Response rate (complete response, unconfirmed complete response, partial response)

Secondary Outcome Measures

Progression-free survival, failure-free survival, and overall survival

Safety profile

Rate of adequate stem cell collection

This will be assessed only for patients eligible for stem-cell transplantation after completion of R-Gemzar/Navelbine therapy

Full Information

NCT ID

NCT00881387

First Posted

April 14, 2009

Last Updated

December 14, 2016

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00881387

Brief Title

Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment

Official Title

A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Withdrawn

Study Start Date

February 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with gemcitabine and vinorelbine may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not responded to treatment.

Detailed Description

OBJECTIVES: Primary Assess the response rate (complete response/remission, unconfirmed complete response, partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma treated with 3 courses of rituximab, gemcitabine hydrochloride, and vinorelbine ditartrate. Secondary Assess progression-free survival, failure-free survival, and overall survival of patients treated with this regimen. Characterize the safety profile of this regimen in these patients. Determine the rate of adequate stem cell collection (≥ 2 million CD34+ cells) in patients eligible for stem cell transplantation. OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem cell transplantation (SCT). Group 1 (eligible for SCT): Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT. Group 2 (ineligible for SCT): Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed for at least 2 years.

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, adult lymphocyte depletion Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma, adult mixed cellularity Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (eligible for SCT)

Arm Type

Experimental

Arm Description

Arm Title

Group 2 (ineligible for SCT)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

rituximab

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

vinorelbine ditartrate

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Response rate (complete response, unconfirmed complete response, partial response)

Time Frame

After first 3 cycles of treatment

Secondary Outcome Measure Information:

Title

Progression-free survival, failure-free survival, and overall survival

Time Frame

Treatment start date to date of death for any reason

Title

Safety profile

Time Frame

Cycle 1 Day 1 through Follow-up

Title

Rate of adequate stem cell collection

Description

This will be assessed only for patients eligible for stem-cell transplantation after completion of R-Gemzar/Navelbine therapy

Time Frame

After completion of 3 cycle of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following cell types: Nodular sclerosis Mixed cellularity Lymphocyte-rich Lymphocyte-depleted Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy No known CNS metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-1 ANC > 1,500/mm^3 Platelet count > 75,000/mm^3 Total bilirubin ≤ 2 mg/dL (unless due to hemolysis) AST or ALT ≤ 2.5 times upper limit of normal Creatinine normal OR creatinine clearance ≥ 50 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active hepatitis B infection No known chronic hepatitis B carrier No HIV positivity No concurrent uncontrolled illness including, but not limited to, any of the following: Symptomatic neurological illness Active uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of study treatment Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Significant pulmonary disease or hypoxia Psychiatric illness or social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 14 days since prior chemotherapy, immunotherapy, biological therapy, or investigational therapy and recovered No prior gemcitabine hydrochloride, vinorelbine ditartrate, or rituximab No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandra Stefanovic, MD

Organizational Affiliation

University of Miami Sylvester Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

University of Miami Sylvester Comprehensive Cancer Center - Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment

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