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

NCT00881387 | Withdrawn Phase 2 DMC

• 2 other identifiers: 20080919SCCC-2007092
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  After first 3 cycles of treatment

Secondary Outcomes (3)

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

  Treatment start date to date of death for any reason

• Safety profile

  Cycle 1 Day 1 through Follow-up

• Rate of adequate stem cell collection

  After completion of 3 cycle of treatment

Study Arms (2)

Group 1 (eligible for SCT)

EXPERIMENTAL

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.

Biological: rituximab; Drug: gemcitabine hydrochloride; Drug: vinorelbine ditartrate

Group 2 (ineligible for SCT)

EXPERIMENTAL

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.

Biological: rituximab; Drug: gemcitabine hydrochloride; Drug: vinorelbine ditartrate

Interventions

rituximab BIOLOGICAL

Given IV

Group 1 (eligible for SCT); Group 2 (ineligible for SCT)

gemcitabine hydrochloride DRUG

Given IV

Group 1 (eligible for SCT); Group 2 (ineligible for SCT)

vinorelbine ditartrate DRUG

Given IV

Group 1 (eligible for SCT); Group 2 (ineligible for SCT)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Rituximab; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Alexandra Stefanovic, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)